306 Mdr Jobs - Page 6

Job Title: QARA Lead Experience: 3–6 years Location: Bengaluru, India (IISc Campus) Responsibility : Quality Management System: Architect, implement, and maintain a lean, audit-ready ISO 13485:2016 Quality Management System (QMS). Drive certification and act as Management Representative (MR) for audits and regulatory inspections. Regulatory Strategy & Submissions: Define and execute regulatory strategies for CDSCO (Class II/III), FDA 510(k), and EU MDR CE Mark. Prepare, review, and submit regulatory dossiers; interact with authorities and notified bodies. Design Control & Documentation: Own all design-control documentation (SRS, DHF, Risk Management File, DMR, Technical File, etc.) in collaboration with engineering teams. Translate regulatory requirements into actionable tasks for engineers. Compliance & Standards: Ensure compliance with ISO 13485, ISO 14971, IEC 60601, IEC 62304, and Indian MDR 2017. Maintain strong exposure to IEC 60601 and other applicable standards for Class C active medical devices. Internal Audits & CAPA: Plan and conduct internal audits, manage CAPA investigations, and lead continuous-improvement initiatives. Supplier & Manufacturing Oversight: Qualify and monitor suppliers/CMOs; establish incoming/in-process quality controls and batch-release records. Support or lead the process for obtaining CDSCO manufacturing licenses. Training & Change Control: Train cross-functional teams on standards, good documentation practices, and change-control procedures. Post-Market Surveillance: Set up post-market surveillance, complaint handling, and vigilance procedures ahead of product launch. Requirment : Education: Bachelor’s degree in Engineering (preferably Biomedical), Life Sciences, or related field. ISO 13485 internal-auditor certification preferred. Experience: 4–6 years of QARA experience with Class II or higher medical devices, ideally in a startup or small-team environment. Hands-on experience with Class C active medical devices. Technical Skills: Demonstrated implementation of ISO 13485 QMS, compilation of CDSCO dossiers, and/or FDA/CE submissions. Strong understanding of technical specifications, schematics, test protocols, and engineering terminology. Regulatory Knowledge: Working knowledge of ISO 14971, IEC 60601, IEC 62304, Indian MDR 2017, EU MDR, and FDA 510(k) processes. Other Skills: Excellent documentation skills, analytical mindset, and ability to work independently in a fast-paced startup environment. Strong communication and training abilities. Show more Show less

Company Profile Since year 2003, Oceaneering’s India Center has been an integral part of operations for Oceaneering’s robust product and service offerings across the globe. This center caters to diverse business needs, from oil and gas field infrastructure, subsea robotics to automated material handling & logistics. Our multidisciplinary team offers a wide spectrum of solutions, encompassing Subsea Engineering, Robotics, Automation, Control Systems, Software Development, Asset Integrity Management, Inspection, ROV operations, Field Network Management, Graphics Design & Animation, and more. In addition to these technical functions, Oceaneering India Center plays host to several crucial business functions, including Finance, Supply Chain Management (SCM), Information Technology (IT), Human Resources (HR), and Health, Safety & Environment (HSE). Our world class infrastructure in India includes modern offices, industry-leading tools and software, equipped labs, and beautiful campuses aligned with the future way of work. Oceaneering in India as well as globally has a great work culture that is flexible, transparent, and collaborative with great team synergy. At Oceaneering India Center, we take pride in “Solving the Unsolvable” by leveraging the diverse expertise within our team. Join us in shaping the future of technology and engineering solutions on a global scale. Position Summary The Document Controller is specialist who manages various aspects of document control, including numbering, filing, sorting and retrieval of electronically stored documentation produced by technical teams, projects or departments in a timely, accurate and efficient manner. The position’s purpose is to provide document control services on time with high quality by ensuring that the processes are followed. ESSENTIAL Duties And Responsibilities Maintain a OMR Master Document Register (MDR) consisting of drawings, specifications, procedures and plans Setup and maintain OMR data in the PLM. Monitor due dates for drawings, specifications, software, technical manuals and other documents. Also Monitor the status of project to ensure documentation is submitted according to schedule. Manage the flow of correspondence in and out of the company through proper transmittals; ensure outgoing documents are accurate, comply with company standards and policies, route correspondence to correct associates; and protect and secure confidential and proprietary information. Responds in a timely manner to requests to retrieve information, information searches and general requests for support from project/department personnel. Allocate and control the document numbering system for the project work. Reviews and verifies project documents for completeness, format, and compliance with contract requirements. Submits project documentation to management team for approval and transmits approved documents to customer. Distributes documentation to the project team and customers for review and comments. Create document objects and attach appropriate files. Engage in document migration projects as required. Generate the various document control reports as required. Provide the quality of deliverables and maintain quality records (KPI's). Database Management using helpdesk and knowledge base software like Business Intelligence, Smart Sheets, etc. with precision. Prepare customized reports and dashboards for Operations, Technical Departments, and Senior management. Identify, Evaluate, and Interpret trends for detailed analysis of data. Collaborate with cross-functional teams to address any support needs related to BUs supported, ensuring seamless integration with overall project objectives. NON-ESSENTIAL Undertake continuous improvement training programs and specific projects as instructed by management. Support Quality Management System implementation and drive Continuous Improvement process. Do additional administrative /technical jobs as assigned Safety Ensure that the Safety policies and procedures are understood and adhered to so far as is reasonably practicable in order to proactively ensure a safe working environment. Carry out work in accordance with the Company Health, Safety, Environmental and Quality Systems. Proactively identify workplace hazards and suggest improvements to enhance the safety and quality of the work environment. Other Perform the assigned tasks with due diligence regarding the Integrated Management Systems on the Company. Eliminate waste of whatever form, to suggest the use of more environmentally friendly substances and practices and contribute to the continuous improvement of the environment. Supervisory Responsibilities This position will This position has NO direct supervisory responsibilities. Reporting Relationship Direct Reporting to Manager, Robotics Support Centre Qualifications REQUIRED Required Bachelors in Science / Commerce / PGDCA/ BCA or other relevant educational field. 0 - 2 years of practical experience as Document Controller or equivalent position Good knowledge of Microsoft applications, especially of Excel and word Able to work in Night shifts 42.5 hours (weekly) (E) Knowledge of MS-Office and computer fundamentals (E) Must be willing to Work from office as and when needed. Strong analytical skills with the ability to interpret complex data sets and generate actionable insights. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. DESIRED Exposure with PLM / PDM or Other Document management tools is highly desirable. Knowledge, Skills, Abilities, And Other Characteristics Excellent Verbal & Written Communication Skills in English Creative thinking and teamwork skills Possessing a proactive, positive, “can-do” attitude Gives and receives constructive feedback. Able to perform multitasking. Ensures that others involved in a project or effort are kept informed about developments and plans How To Apply Oceaneering provides equal employment opportunities to all applicants. How To Apply Regular full-time employees who apply will be considered along with external candidates. Employees with less than six months with their current position are not eligible to apply for job postings. Please discuss your interest in the position with your current manager/supervisor prior to submitting your completed application. It is highly recommended to apply through the PeopleSoft or Oceanet portals. How To Apply In addition, we make a priority of providing learning and development opportunities to enable employees to achieve their potential and take charge of their future. As well as developing employees in a specific role, we are committed to lifelong learning and ongoing education, including developing people skills and identifying future supervisors and managers. Every month, hundreds of employees are provided training, including HSE awareness, apprenticeships, entry and advanced level technical courses, management development seminars, and leadership and supervisory training. We have a strong ethos of internal promotion. We can offer long-term employment and career advancement across countries and continents. Working at Oceaneering means that if you have the ability, drive, and ambition to take charge of your future-you will be supported to do so and the possibilities are endless. Show more Show less

Job Description– Associate Agency Development Manager job summary : Responsible for  Agent Recruitment  Agent Development  Meet Business targets  Customer Centricity Key Responsibilities: Agent Recruitment  Develop various sources of agent hiring & build a team of agent & agent pipe line.  Conduct activity to enhance existing agent footfall to generate fresh referral for new agent hiring  Implementation of MLI GOLD process and adhere to the business norms  Follow agent 9 pointer hiring mechanism & other hiring norms Agent Development  Ensure product knowledge by MLI ways of training  Field demonstration (FOD’s)  Development of agent prospecting habits, calling habits and work habits.  Workwithagent onplanning and reviewing of activities and goals.  Identify the training needs of the agent and work with Trainers to improve the same Meet Business Targets  Achievement of monthly, quarterly & yearly business plans.  Improve agent productivity & persistency by regular PRP/IID/GID etc…  Ensure companies product mix sales ration and adhere to the business norms.  Maintain agent pro activity as per business plan Customer Centricity  Be MLI brand ambassador &a customer champion  Follow MLI sales practice to develop deep customer loyalty  Hold periodical customer meet to understand customer pulse & nee  Ensure customer queries are responded to satisfactorily as per MLI standard. Desired Competencies  Sourcing &Selection capability  Nurturing & Developing talent  Result orientation  Customer centricity  Planning &Execution MOS:  Achievement of business plan & GPA  Recruitment / Development & Activisation of agent as per plan.  Persistancy as per MLI grid  Achieve GOLD Score as per MLI standard  Number of EC/MDR Tagent Minimum Education:  Graduation. CTC : 2.00 LPA to 3.50 LPA Candidate Specification  Age between 24-38 years  Work experience not less then 2 years in sales Job Types: Full-time, Permanent Pay: ₹350,000.00 per year Benefits: Health insurance Schedule: Day shift Supplemental Pay: Performance bonus Yearly bonus Work Location: In person

Position - Senior Manager Location - Noida Education - Graduate or Postgraduate degree/BTech. Professional Qualifications - ISO 13485 Lead or Internal Auditor. EDMS Management or auditing. Role Description – Task and Responsibilities: Act as the lead internal auditor for medical device programs, ensuring compliance with ISO 13485 and U.S./EU regulations. Investigate non-conformances and implement effective corrective actions for medical device-related issues. Review onboarding checklists to ensure FDA and EU MDR requirements are met for all devices. Oversee compliance in shipping, labeling, and depot processes for investigational and commercial devices. Serve as the main contact during ISO 13485 audits and coordinate with logistics and external auditors. Monitor regulatory changes (FDA, EMA, MDR) and update quality systems accordingly. Administer the EDMS platform, managing system operations, user support, and maintenance. Manage controlled document lifecycles, ensuring version control, timely reviews, and audit readiness. Promote compliance awareness across delivery teams and collaborate with cross-functional stakeholders. Demonstrate strong problem-solving, communication, and virtual collaboration skills, with the ability to explain risk to non-technical teams. Required Experience and Educational Qualification: 10+ years of experience in medical device compliance or quality roles within the pharma, biotech, or medical device industry. Proven expertise in ISO 13485 implementation, audit participation, and regulatory compliance. Solid understanding of FDA 21 CFR Part 820, EU MDR (Regulation (EU) 2017/745), and international medical device standards. Experience with depot and shipping logistics for clinical or commercial medical devices. Strong analytical, documentation, and communication skills. Familiarity with EU authorized representative and UDI requirements. Knowledge of document control processes in support of GxP operations (GMP, GVP, GCP). Familiarity with change control, IT compliance, and CAPA systems. Show more Show less

Job Description Job Overview: The Senior Quality Inspector uses best practices and knowledge of internal or external issues to improve the inspection discipline within McDermott. They will act as a resource for colleagues with less experience and share their conceptual and practical expertise related to the inspection discipline. The Senior Quality Inspector solves complex problems and uses discipline-specific knowledge to improve their products or services. The Senior Quality Inspector impacts a range of customer, operational, project, or service activities with the inspection team and other related teams and ensures that they work within the appropriate guidelines and policies. Responsibilities Key Tasks and Responsibilities: Liaise with Client representatives for day-to-day quality related activities on the project Establish Site Quality Management System Understand MDR & Client Quality requirements and cascade down to Site team for implementation Preparation of PWPS, Conducting WPS Qualification, Witness Lab tests, Welder Qualification Tests, Electrode Qualification Tests Perform Welding Inspection as per applicable Project Procedure, Standards & Codes Review of Welding Documents (Batch Test Certificates) of Welding Consumable Maintain record of Welder Performance and Weld Repair Rate Liaise with the assigned ND Contractor to determine the timely completion of the assigned task Review of NDT Procedures (i.e., UT, PT, MT, RT, PAUT & ET) Review Certification documents of NDT Technicians Witness NDT Activities and (i.e., UT, PT, MT, RT, PAUT & ET) and Determine acceptance / rejection based on the defined criteria Perform RT Film review as per Applicable acceptance Codes and Standard Ensure proper maintenance of NDT equipment and maintain equipment certification records Conduct / Participate in planned audits during project execution phase and ensure compliance to the Quality Management System, Local Statutory requirements and Project Specification requirements Demonstrated skills in inspection activities of welding & NDT Ensuring compliance to quality standards and maintaining all related documents Interfacing during fabrication & installation process to resolve any welding and NDT related problems Qualifications Essential Qualifications and Education: Bachelor’s / Diploma in Mechanical Engineering / Metallurgy For Mechanical, Composite EPC or EPCC contracts of value more than Rupees 20 Crores, the Lead Welding /NDT Engineer shall also possess Certified Welding Inspector Qualification from American Welding Society or CSWIP 3.1 Welding Inspector Qualification from the Welding Institute UK Level II in RT Collaborative and Team player Work as a Project team member with right attitude and Professionalism Excellent communication and Interpersonal skills Go Beyond attitude Preferred Qualifications and Education: 15+ years preferred for B.E / B. Tech or 20+ years preferred for Diploma About Us Lutech Resources has over 25 years’ experience providing tailor made recruitment and integrated resource management to leading Engineering, Energy and Manufacturing sector companies worldwide. We set ourselves apart from others in the industry by building long term relationships with both our clients and candidates based on a mutual understanding of their targeted industry and a passion for excellence. With every engagement, our goal is to quickly place qualified talent with the best suited employer. We have a genuine understanding of candidates and clients’ needs. Along with a dynamic and effective service, we strive for positive outcomes for everyone, every time. Show more Show less

Operating Company: Kerr Location: Mumbai,Maharashtra,IN Date Posted: June 4, 2025 Req Number: R5022857 Job Description: Working closely with the Global Regulatory Affairs team, you'll be responsible for planning, scheduling, and managing the preparation and submission of regulatory applications to local authorities, including support for EU MDR submissions and approvals. Ensure all marketed devices secure and maintain necessary regulatory approvals, managing registration processes according to both regulatory guidelines and internal company procedures. Proactively maintain an up-to-date project tracker, ensuring all information is current and accurate. Collaboration with the Business Manager and Dealers is crucial to identify and mitigate potential supply chain risks Completes other regulatory activities as assigned by Department Head. Job Requirements: Critical Skills Graduate / Postgraduate preferably in Life Sciences or equivalent. 3-5 years Industry Experience in Regulatory Affairs, preferably in medical devices. Knowledge and competency in application of Local regulations D&C Act and Rules, MDR 2017 Good spoken and written of English language. Proficient in the use of MS Word, Excel and PowerPoint Other desired skills : Able to work independently and possess great sense of responsibility, accountability and Highly motivated to take ownership, adaptable to change, and receptive to innovative approaches. Proficient in the use of MS Word, Excel and PowerPoint. Fostering collaboration with key stakeholders. Possesses strong project management skills. Good working attitude. Critical thinking and problem-solving. Strong communication skills. Operating Company: Kerr Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

Summary Data has never been more valuable and vulnerable. As cybercriminals become more sophisticated and regulations more strict, organizations struggle to answer one key question: “Is my data safe?" At Varonis, we see the world of cybersecurity differently. Instead of chasing threats, we believe the most practical approach is protecting data from the inside out. We’ve built the industry’s first fully autonomous Data Security Platform to help our customers dramatically reduce risk with minimal human effort. At Varonis, we move fast. We’re an ultra-collaborative company with brilliant people who care deeply about the details. Together, we’re solving interesting and complex puzzles to keep the world’s data safe. Position Overview : Varonis MDR team is at the forefront of worldwide data detection and response services. We lead and redefine how data should be monitored, and protected and how data breach incidents should be handled. It’s a 24/7 global security service assisting customers to investigate and respond to security incidents. We are seeking an experienced MDR Team Lead who will oversee a team of MDR Security Analysts. This oversight includes training and developing the knowledge and skills needed to execute the MDR mission, ensuring adherence to all operating policies and procedures, ensuring the delivery of the MDR service within all SLAs, and serving as a point of technical and operational escalation for MDR analysts. Data is the #1 target of attackers, and Varonis' Managed Data Detection and Response (MDDR) customers entrust our team with the security of their data. MDR Team Leads are the lynchpin of MDR operations, ensuring the team is working 24x7 to monitor, triage, investigate, and escalate incidents where data is at risk and to ensure we meet operational SLAs. Responsibilities : Technical and operational escalation point for investigations, incidents, and other elements of the MDR service. Assist in the development, documentation, analysis, testing, and modification of Varonis’ threat detection systems, playbooks, runbooks, and MDR team operations. Continuously train the team so they are equipped with the required skills and knowledge to effectively execute the MDR service. Validate findings and coordinate investigative efforts with customers and internal teams. Ensure all investigative findings are documented and communicated appropriately by the team, including tracking in CRM. Maintain up-to-date knowledge of all aspects of Varonis MDR service. Oversee and execute programs, projects, operational tasks, and responsibilities related to the MDR service. Conduct regular performance reviews and quarterly SWOT analyses to drive team growth and development. Requirements: Proven success in leading and managing within a team-oriented environment. 4+ years of experience working in cybersecurity operations in a global cybersecurity company 2+ years of experience leading a team. Degree or certification(s) in cybersecurity and/or proven ability to execute across cybersecurity operations disciplines, including monitoring, detection, investigation, and incident response. Proven ability to deliver security operations service while meeting SLA and other operational requirements. Knowledge of common security technologies and tools including network-based (firewall and IDS), host-based (EDR and AV), data-based (DLP and DSPM), and identity-based (PAM and IAM). Proven ability to creatively problem-solve when handling complex issues. Strong analytical and critical thinking skills. Excellent communication skills in English (written and oral) and interpersonal skills (direct reports, colleagues, and customers). Attention to detail and the capability to deliver outcomes autonomously. We invite you to check out our Instagram Page to gain further insight into the Varonis culture! @VaronisLife Varonis is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other legally protected characteristics. Show more Show less

Responsibilities New product design & development initial stage to production stage. Benchmarking of the product. Test and record performance of components, products & manufacturing methods. Analyze and resolve technical issues associated with components, products, manufacturing methods and performance. Prepare bill of materials (BOM), design specifications & raw materials specifications etc. Conduct failure mode & risk analysis according to ISO 13485. Responsible for product design verification & validation and maintain its records. Ensuring Manufacturing performance and Quality goals are met. Prepare and review documentation history files (DHFs). . Maintain and improve existing product manufacturing processes. Anticipate Manufacturing’s need for new products and fixtures. To be involved in the assembly, troubleshooting, testing, and repair activities of our products. Provide instruction and support to Manufacturing and QA on manufacturing techniques, procedures, and QC inspections. Survey and identify replacement components for reasons of obsolescence or cost reduction. Identify and contact vendors. Compare technical specifications. Compile and prepare required documentation. Assure the timely manufacturing, packaging, and delivery of new products. Identify, source, and implement improvements in manufacturing procedures. Coordinate relationships with vendors and contractors. Responsible for on-going process improvement: take initiative to define, plan, and execute improvement projects, achieve objectives in increasing yields, reducing cycle time, reducing overall cost, and improving product quality and reliability. Education Butcher of Engineering or Equivalent Experience Required minimum 5 year experience in medical device industries. Knowledge and Training Strong knowledge of medical devices product design and development process. Knowledge of injection multi cavity injection mould, die, fixture and machine design. Knowledge of design and drawing change control procedure. Ability to assess the feasibility of design modifications to existing designs. Experienced in troubleshooting and recommending corrective or preventive actions to improve product reliability. Experienced in interfacing with functional groups outside of engineering Good communication skills, verbal and written Knowledge of ISO 13485 / MDR 2017 Strong interpersonal and collaborative skills. Works well as a supportive team member. Knowledge of CAD software Solid Works is desirable. Contact Person: Mr. Amit Kumar Contact Number: +91 9560043049. Email ID: hr@maisindia.com Job Category: Product Development Job Location: Gurugram Show more Show less

Job Summary : This role to ensure that all sterile medical devices manufactured at the plant meet the highest standards of quality, safety, and compliance. He / She must have strong understanding of regulatory requirements (such as ISO 13485, Indian Medical Device Rule-2017 etc) with respect to inspection & testing, and hands-on experience with quality control processes in a cleanroom or GMP-compliant environment. Key Responsibilities: Supervise the team perform in-process and final inspection of sterile medical devices and components. Conduct sampling, testing, and documentation of raw & packaging materials, finished goods, sales return product, Stability study etc. Involve customer complaint investigation process and prepare necessary investigation reports. Ensure compliance with applicable regulatory standards (ISO 13485,IMDR, MDR etc.). Maintain and calibrate QC instruments and equipment. Prepare and review QC documentation, including SOP's, inspection reports, COA, and deviation reports. Participate in internal audits and support external regulatory inspections. Identify and report non-conformities and assist in root cause analysis and CAPA implementation. Collaborate with production, R&D and QA teams to ensure product quality. Maintain cleanroom protocols and hygiene standards during inspections. Qualifications & Skill Bachelor’s degree in Science, Engineering, Pharmacy, or a related field. 4-6 years of experience in quality control within the medical device industry. Familiarity with GMP, ISO 13485, and IMDR regulations. Proficient in using QC tools and instruments Strong documentation and analytical skills. Good communication and teamwork abilities. Experience with statistical quality control (SQC) and SPC tools. Show more Show less

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force . We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below. Roles and responsibilities: Responsible for authoring Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Post-Market Surveillance Reports (PMSR), Periodic Safety Update Reports (PSUR), Annual Summary Reports (ASR), Post-Market Clinical Follow-up Plans and Evaluation Reports(PMCFP/PMCFER) Acquire knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature Develop literature search and data extraction strategy for search, screening, and summarization of articles, and develop in-depth knowledge and understanding of current scientific literature Participate in and/or perform comprehensive literature searches to support identified product lines and related clinical studies Stay informed about applicable clinical landscapes and trends Review literature search results and interpret and summarize risks, alternate therapies and device specific benefits; collect and summarize primary data to support risk assessment Critically appraise scientific literature and write clinical summaries for products literature to elucidate the clinical problem and current treatment techniques Evaluate data for similar competitor devices Perform data fact check of the documents authored Collaborate with the project/program stakeholders for product information to develop quality content for CERs, within the required timelines Manage assigned client account and ensure successful on time delivery of all deliverables as listed in the SoW Responsible for end to end technical execution of the project Work with PMO to ensure resources with the right skill set are assigned to the project Work with PMO for resource allocation and end-to-end project plan Act as client point of contact for day-to-day communication and project execution Guiding writers on end-to-end execution of the assigned deliverable Day-to-day communication with primary and supporting writer for project execution Review queries for project Kick-off meetings and status update calls Review assets tracker Guiding team members in product understanding, gathering inputs, literature search strategy and systematic literature review, literature screening and data extraction Working as subject matter expert for reviewing, revising and improving the quality of scientific content and content created by primary writers Skills: Experience in leading a team Experience in creating process flows, SOPs, Templates Good understanding of medical devices and an overall understanding of the medical field In-depth knowledge of EU MDR, MEDDEV 2.7.1 Rev 4, IMDRF and MDCG; translate the client requirements and apply in drafting of CE documents Good knowledge on EU MDR specifics related to Clinical Evaluation, Clinical risks and Benefits, Safety and Performance etc Strong flair and passion for technical writing Strong written and verbal communication/presentation skills Being up-to-date with the latest technical/scientific developments and relating them to various projects Ability to understand client requirements and KPIs Qualifications: Graduate or Post Graduate in Life Sciences (Pharm.D/M.Pharm/BDS/MBBS) or Bio Medical Engineering with 5 to 7 years experience 4+ experience in med device clinical affairs domain Sound experience in the application of therapeutic and device knowledge for development of clinical evaluation documents Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report development. Strong experience in conducting literature searches, reviews and appraisal of the scientific data Clear and effective communication, both verbal and written Excellent critical and analytical thinking skills Review experience in clinical evaluation (CEP/CER/SSCP) and post-market deliverables (PMSR/PSUR/PMCFP/PMCFER), IVDRs (PEP/PER) High level of attention to detail and accuracy Able to work effectively withcross-functional teams Able to manage multiple projects across numerousdisciplines. Strong communication, presentation and interpersonal skills with high attention to detail and organization Consistent dedication and strong work-ethic to help meet aggressive timelines or multiple projects when necessary People management, with ability to manage a team of 3-5 writers EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics. Show more Show less

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force . We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below. Roles and responsibilities: Responsible for authoring clinical evaluation reports, clinical evaluation plans, post-market surveillance reports, and periodic safety update reports Act as client point of contact for day-to-day communication for the assigned deliverable Draft queries for Project Kick-off meeting/call Develop & maintain the assets tracker related to the deliverable Review received assets from client, update tracker and request for additional source documents as required Align with Peer-reviewer and Technical project lead on planned timelines for release of the deliverable Acquire knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes Participate in and/or perform comprehensive literature searches to support identified product lines and related clinical studies Stay informed about applicable clinical landscapes and trends Review literature search results and interpret and summarize risks, alternate therapies and device specific benefits; collect and summarize primary data to support risk assessment Critically appraise scientific literature and write clinical summaries for products literature to elucidate the clinical problem and current treatment techniques Evaluate data for similar competitor devices Perform data fact check of the documents authored Ensure documents comply with the client/regulatory requirements Participate in client calls per project requirements Compliance to quality, confidentiality, and security Adhere and follow quality systems, processes and policies Comply to training and specifications Ensure all the open action items in the drafts (if any) are notified to Client Responsible for collation of medical writer and reviewer CVs and DOIs Perform a self Quality Check before sharing draft for review, update and sign the checklist Draft client calls MoMs and share with client for the assigned deliverable Guide writers in the team for literature search and clinical evaluation plans and reports Peer review, quality check, and data fact check of drafts received from writers Feedback on quality and formatting observations to writers Skills: Solid understanding of medical devices and a broad knowledge of the medical field Familiarity with key regulatory frameworks, including EU MDR, MEDDEV 2.7.1 Rev 4, IMDRF, and MDCG guidelines Demonstrates a strong passion for technical writing and scientific documentation Excellent written, verbal, and presentation skills for clear and effective communication Keeps abreast of the latest scientific and technical developments and integrates relevant insights into ongoing projects Qualifications: Graduate or Post Graduate in Life Sciences (Pharm.D/M.Pharm/BDS/MBBS) or Bio Medical Engineering with 4 to 6 years experience 3+ experience in med device clinical affairs domain Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report development. Strong experience in conducting literature searches, reviews and appraisal of the scientific data Clear and effective communication, both verbal and written Excellent critical and analytical thinking skills. Able to work effectively with cross-functional teams. Able to manage multiple projects across numerous disciplines. Strong communication, presentation and interpersonal skills with high attention to detail and organization. Consistent dedication and strong work-ethic to help meet aggressive timelines or multiple projects when necessary EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics. Show more Show less

Cyderes (Cyber Defense and Response) is a pure-play, full life-cycle cybersecurity services provider with award-winning managed security services, identity and access management, and professional services designed to manage the cybersecurity risks of enterprise clients. We specialize in multi-technology, complex environments with the in speed and agility needed to tackle the most advanced cyber threats. We leverage our global scale and decades of experience to accelerate our clients’ cyber outcomes through a full lifecycle of cybersecurity services. We are a global company with operating centers in the United States, Canada, the United Kingdom, and India. About the Job: We are seeking a highly experienced and strategic Principal Threat Researcher to lead advanced threat research initiatives and drive innovation in our threat intelligence program. In this senior-level role, you will uncover, analyze, and track advanced cyber threats, develop detection capabilities, and provide actionable intelligence to protect our customers, infrastructure, and global operations. As a thought leader in cybersecurity, you will collaborate across security, engineering, and executive teams to anticipate evolving threats, influence detection strategy, and contribute to the broader security community through cutting-edge research. Responsibilities: Function as a centralized malware reversing team for the company's needs. (support DFIR, Hunters, MDR, etc.) Track threat actors and campaigns via malware research, code reuse, infrastructure usage, general threat profiling Lead the discovery and analysis of advanced persistent threats (APTs), malware campaigns, and novel attack techniques Develop and maintain high-fidelity threat intelligence feeds and indicators of compromise (IOCs) Perform in-depth malware reverse engineering, exploit analysis, and behavioral analysis Drive strategic threat modeling and horizon scanning to anticipate future adversary behaviors. Collaborate with security operations, incident response, and product teams to build effective detection, prevention, and response mechanisms Publish research findings in whitepapers, blogs, and at conferences to share insights with the global security community Mentor junior researchers and contribute to team development and capability building Establish and maintain relationships with external intelligence communities, law enforcement, and trusted partners Requirements: 8+ years of experience in threat intelligence, threat research, or a related cybersecurity field Proven experience conducting complex investigations into malware, threat actor TTPs, or large-scale campaigns Strong proficiency in malware analysis tools (IDA Pro, Ghidra, Radare2), memory forensics, and reverse engineering In-depth knowledge of attacker techniques (MITRE ATT&CK), network protocols, and operating system internals (Windows, Linux, macOS).Proficiency in scripting or programming (Python, Go, C/C++) for automation and tooling Strong written and verbal communication skills with the ability to translate technical findings into business-relevant insights Skilled in writing concise, compelling, and actionable intelligence reports in English Able to lead intelligence briefings with customers in English Preferred: Experience with threat hunting and detection engineering in a cloud or enterprise environment Familiarity with cybercrime ecosystems, ransomware groups, nation-state threats, or dark web monitoring Contributions to public threat intelligence reports, CVEs, or open-source security tools Security certifications such as GIAC GREM, GCFA, OSCP, or equivalent Cyderes i s an Equal Opportunity Employer (EOE). Qualified applicants are considered for employment without regard to race, religion, color, sex, age, disability, sexual orientation, genetic information, national origin, or veteran status. Note: This job posting is intended for direct applicants only. We request that outside recruiters do not contact us regarding this position. Show more Show less

Job Description Job Overview: Perform conceptual, FEED, Studies, and detailed analyses and design as per design basis, project specifications, design codes and standards. Direct Engineering team as a Lead Engineer on small projects. Apply knowledge and skills to a wide range of standard and nonstandard situations. Prepare clear and accurate detailed design calculations and analyses including design reports and procedures. Manage own time to meet agreed deadlines and budgets and develop plans for short-term work activities in own area. Clearly communicate and explain complex issues and work to establish understanding. Responsibilities Key Tasks and Responsibilities: Be fully familiar with the project scope of work, specifications, schedule and all inter-discipline requirements; including identifying concerns as early as practicable and taking appropriate initiatives to address the issues Identify changes to scope and promptly raise change notifications, including providing any necessary supporting documentation and estimates. Provide similar support for Variation Orders Interface with other departments to obtain input for Discipline designs and drawings Maintain close co-ordination with other engineering disciplines, Planning, Fabrication, Marine, and Project Management Team, as required Assist in preparation of estimates for bid proposals, including technical query reviews, execution statements and manhour estimates Prepare Discipline engineering design basis, philosophies, and technical specifications, as required Participate in finalizing deliverables lists and deliverables, ensuring compliance with specifications and functional integrity Attend project review meetings, vendor meetings, engineering meetings and offshore site surveys, as required Provide technical direction and review of Designers producing products related to Fire Protection & Safety Engineering Prepare and review design reports and procedures Assist in providing necessary design inputs to other disciplines to enable them in proceeding with their deliverables Assist procurement personnel in procuring Discipline equipment, materials and services; ensuring that work produced complies with Customer objectives and procedures. Procurement assistance includes preparing and reviewing requisitions, evaluating technical quotations and preparing queries, compiling bid tabulations and recommendations, preparing purchase requisitions, and coordinating with Procurement to expedite vendor documents, as directed by Discipline Lead Engineer Assist in updating weight report based on receipt of vendor information Check engineering performed by others within Discipline (interdiscipline checks) Review vendor and subcontractor submittals, checking for compliance with project specifications and providing comments as necessary Perform design verification through single-discipline check/ inter-discipline check (IDC) Keep the Lead Engineer/ PEM apprised of all activities and concerns, technical, budgetary and manpower related Assist in providing inputs for actual, planning and forecasting progress reports including associated productivity Check final subcontractor and vendor data manuals to ensure that all requested data has been received and approved Participate in internal, Customer and third party technical audits on engineering deliverables and vendor documents Assist Lead Engineer with responses to Customer and other agencies (such as certifying authorities, auditors, third parties, etc.) on their review and approval Capture lessons learned and enter into MDR's Lessons Learned system Guide less experienced engineers on MDR and Discipline procedures, standards, worksheets, design calculations, software, requisitions, technical bid evaluations, technical queries, etc. Prepare design HSE & fire protection philosophies Prepare safety study scope of work specifications, requisitions, TBE and purchase requisitions Prepare/ review safety equipment lists Prepare/ review firefighting equipment specifications and data sheets Prepare/ review life saving and personnel safety equipment specifications and data sheets Prepare/ review safety sign specifications and data sheets Prepare / review firewater demand and hydraulic calculation reports using PIPENET or equivalent software Prepare, review, and provide inputs to P&ID markups for Firewater ring main system and Deluge system including providing details of interconnection with hose reels, monitors, hydrants and deluge valves / nozzles Prepare/ review escape route and safety equipment layouts Prepare / review safety sign layouts Review third party safety study reports that are in compliance with project specifications Participate, assist Lead Engineer coordinate safety workshops (such as HAZID/HAZOP) and provide inputs to safety study consultants Assist Lead Engineer coordinate safety study close outs and prepare safety study close out reports. Review FP&S and relevant other disciplines' vendor data Prepare / review technical notes on PFP rating requirements for the project based on Safety Study recommendations Provide inputs for FP&S layouts, fire and gas detector layouts and fire and gas cause and effects matrices Prepare/ review safety study safety action monitoring system (SEAMS) and SEAMS registers Provide and review safety inputs to operations manuals Qualifications Essential Qualifications and Education: 8-15 yrs in oil and gas with major contractor or consultant predominantly performing detail design Bachelor Degree or Master Degree in Engineering Strong working knowledge of many design techniques and analysis methods, and detailed knowledge of the content and application of standards codes and guidelines as applicable About Us Our ingenuity fuels daily life. Together, we’ve forged some of the most trusted partnerships across the energy value chain to make what was once just an idea a reality: laying subsea infrastructure thousands of feet below sea level, installing platforms hundreds of miles from shore, using our expertise to design and build offshore wind infrastructure, and reshaping the onshore landscape to deliver the energy products the world needs safely and sustainably. For more than 100 years, we've been making the impossible possible. Today, we're driving the energy transition with more than 30,000 of the brightest minds across 54 countries. Show more Show less

Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is safer and more secure than the one before. We are a company built on the foundation of challenging and disrupting the way things are done, and we’re looking for innovators who are as committed to shaping the future of cybersecurity as we are. Who We Are We take our mission of protecting the digital way of life seriously. We are relentless in protecting our customers and we believe that the unique ideas of every member of our team contributes to our collective success. Our values were crowdsourced by employees and are brought to life through each of us everyday - from disruptive innovation and collaboration, to execution. From showing up for each other with integrity to creating an environment where we all feel included. As a member of our team, you will be shaping the future of cybersecurity. We work fast, value ongoing learning, and we respect each employee as a unique individual. Knowing we all have different needs, our development and personal wellbeing programs are designed to give you choice in how you are supported. This includes our FLEXBenefits wellbeing spending account with over 1,000 eligible items selected by employees, our mental and financial health resources, and our personalized learning opportunities - just to name a few! At Palo Alto Networks, we believe in the power of collaboration and value in-person interactions. This is why our employees generally work full time from our office with flexibility offered where needed. This setup fosters casual conversations, problem-solving, and trusted relationships. Our goal is to create an environment where we all win with precision. Job Description Your Career We are seeking a driven problem solver to join our Unit 42 MDR team. Our team is responsible for customers internal security monitoring, threat hunting and incident response. As a MDR Analyst, we will rely on you to detect and respond to cyber incidents facing customers’ internal business. The ideal candidate is a quick learner and good communicator who will be able to follow established processes for analyzing threat alerts that fire from our Cortex XDR. The candidate should be a creative thinker who takes pride in solving tough problems. Your Impact Join a new emerging team who is going to be part of Palo Alto’s Unit 42, Working closely with global customers providing the best security in the market Own an incident lifecycle from outbreak to full remediation Provide critical feedback to the different product, research and engineering and threat hunting teams to help improve the products for the entire Palo Alto Networks’ customer base Work closely with Security Research, Threat Intelligence and Threat Hunting teams to remediate and detect new emerging threats This position requires flexibility to work primarily during morning and afternoon hours however, occasional night shifts may be required depending on business demands Qualifications Your Experience 3+ years of experience in a multi tiered SOC/IR is a must Experienced with Technologies such as EDR, SIEM, SOAR, FW A well established familiarity with attack trends and vectors Excellent written and oral communication skills in English Some degree of Malware Analysis or equivalent military experience - An advantage CEH / CompTIA CYSA+ certifications - An advantage Hands-on experience with Cortex XSOAR or Cortex XDR - An advantage Additional Information The Team The team you’ll lead helps protect customers by identifying the most sophisticated & stealthy attacks in their environment. The team does so by leveraging the Cortex product suite as well as unique tools, methodologies and techniques. Cortex provides enterprise-scale detection and response that runs on integrated endpoint, network and cloud data — reduce the noise and focus on real threats. This team works closely with the different product teams and helps improve each and every product by providing first-hand insights into how the product is used and how it can perform even better. Our Commitment We’re problem solvers that take risks and challenge cybersecurity’s status quo. It’s simple: we can’t accomplish our mission without diverse teams innovating, together. We are committed to providing reasonable accommodations for all qualified individuals with a disability. If you require assistance or accommodation due to a disability or special need, please contact us at accommodations@paloaltonetworks.com. Palo Alto Networks is an equal opportunity employer. We celebrate diversity in our workplace, and all qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or other legally protected characteristics. All your information will be kept confidential according to EEO guidelines. Covid-19 Vaccination Information for Palo Alto Networks Jobs Vaccine requirements and disclosure obligations vary by country. Unless applicable law requires otherwise, you must be vaccinated for COVID or qualify for a reasonable accommodation if: The job requires accessing a company worksite The job requires in-person customer contact and the customer has implemented such requirements You choose to access a Palo Alto Networks worksite If you have questions about the vaccine requirements of this particular position based on your location or job requirements, please inquire with the recruiter. Show more Show less

Job Purpose: To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction. Key Responsibilities: Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system. Acknowledge receipt of complaints and communicate resolution timelines to complainants. Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements. Coordinate with cross-functional teams (R&D, Quality, Manufacturing, etc.) to investigate root cause(s). Ensure timely and accurate completion of complaint investigations, CAPA initiation (if required), and closure within defined timelines. Document complaint details, investigation findings, corrective actions, and outcomes. Communicate findings and resolutions to stakeholders and customers. Generate monthly/quarterly complaint trend reports and risk assessments. Support external/internal audits and regulatory inspections by providing complaint-related documentation. Maintain compliance with company SOPs, ISO standards, and regulatory requirements. Recommend preventive actions and contribute to quality improvement initiatives. Required Qualifications and Skills: Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, or equivalent field. 3+ years of experience in product complaint handling, preferably in the medical device or pharmaceutical industry. Knowledge of ISO 13485, FDA regulations, MDR, and other global regulatory requirements. Strong analytical, problem-solving, and documentation skills. Familiarity with complaint management software or QMS tools (e.g., TrackWise, MasterControl, etc.). Excellent communication skills – written and verbal. Attention to detail and a commitment to quality and compliance. Preferred Qualifications: Certification in Quality Management Systems or Regulatory Affairs. Experience in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA). Exposure to CAPA, NC, and audit handling processes. Show more Show less

Job Requirements Quest Global is seeking an experienced and highly skilled Lead Engineer: Biocompatibility to lead and support medical devices regulatory compliance efforts. The candidate shall have in-depth knowledge of global medical devices regulations, extensive experience in handling Biocompatibility requirements and a strong ability to guide cross-functional teams in meeting compliance requirements. This role involves leadership, technical expertise and strategic thinking to ensure successful product approvals and lifecycle management Handling Biocompatibility safety gap assessment and Biological evaluation plan Ensure compliance with relevant standards and regulations, including ISO10993, ISO 13485, EU MDR, FDA, ISO 14971, IEC 62366 and other applicable country wise and global requirements Mentor and provide guidance to cross functional Engineers and other team members Ensure compliance of verification, validation and testing protocols with applicable standards Review risk management documentation and clinical evaluations to ensure compliance Provide guidance during product design and development to ensure compliance and minimize risks Work Experience Bachelor's or master’s degree in biomedical engineering, Mechanical Engineering, Electronics Engineering, or related fields. Advanced degrees are preferred. 2-4 years of experience in the medical devices industry Extensive knowledge on biocompatibility of medical device and submission processes Proven experience in working with ISO 10993, FDA, EU MDR and other global regulatory frameworks Strong understanding of medical device design, development, and manufacturing processes Expertise in technical writing and documentation preparation Strong analytical and problem-solving skills with the ability to interpret complex regulatory requirements Excellent leadership, communication, and collaboration skills

MISSION STATEMENT To ensure the quality lifecycle management for dedicated, subcontracted, product portfolio. Qualified auditor. MAIN ACCOUNTABILITIES AND DUTIES Operational skills Operational quality management of a dedicated product portfolio which includes: Quality management of deviation and complaint records and their related CAPAs Assessment and management of change controls Edition of QA Agreements with Zentiva third parties and subcontractors Collection and evaluation of PQRs and stability data Compliance evaluation of Third Parties and products Maintenance of product database Collection and review of CoA/CoC QA support of product launches and transfers GMP, GDP, MDR, HACCP, Food Supplements and Cosmetics regulations and legislations Auditing Prepare audit and audit plans Conduct and participate to external audits Evaluation of audit reports Participate to internal audits and inspections KPI monitoring and reporting Other tasks may be performed under the direction of the Manager within the agreed type and scope of work. OTHER RESPONSIBILITIES QUALITY Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy. HSE Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System. PHARMACOVIGILANCE All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations COMPLIANCE The employee will comply with all internal policies and rules of the Company. The employee will make her/himself acquainted with the Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents. REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS University degree in Pharmacy, Chemistry, Biology, or relevant Life Science Minimum of 5 years in a similar role or equivalent experiences in a GMP related environment Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements Management of subcontractors is an advantage Proven track record of project management skills Strong communication skills and negotiation strength Proactive attitude Problem solving skills Hands-on attitude, flexible and open minded Collaborative and team-spirited Knowledge of IT tools Language - English: Advanced level

How will you CONTRIBUTE and GROW? This procedure defines the detailed work instructions to be followed during project execution for expediting vendor’s activity to ensure - readiness of the equipment and related documentation for manufacturing, inspection and dispatch within contractual delivery dates. This procedure applies to equipment procured from external suppliers during the project. This document does not apply for the expediting of engineering services, which shall be done directly by the concerned engineering discipline and also for the services required at construction sites which shall be done directly by site construction manager. Job Responsiblities : Develop project specific OM/E execution plan for Order Management / Expediting Monitor documents and information to be received from suppliers (organization chart, progress report, fabrication schedule, overview on the critical material for prefabrication). Compile and issue expediting visit reports as well as minutes of meetings held with supplier. Conduct expediting visits to suppliers with reinforced expediting in case of failing suppliers and raise appropriate alert to the project when delay detected. Proactively monitor all supplier activities from design development, material procurement phase, manufacturing and testing process as well as shipping preparation Review vendor progress reports, fabrication schedules and raise appropriate alert to the project in case of deviations. Interface with suppliers and Inspection department to monitor inspection hold and witness points. Expedite the issuance of the Inspection Release Certificate (IRC). Monitor and address delayed critical vendor documentation from supplier based on document status by Doc. Control, Follow up with the suppliers on open points / punch list, in cooperation with various disciplines. Identify potential areas of concerns or delays with deliveries and initiate appropriate corrective actions. Collecting recovery plan from supplier followed by supporting plan review by AL. Enter tracking data and keep up to date the progress management tool (OM/E Dashboard – manual tables or SAP database / ERP system , based on project requirements including reporting to the client if required) Compile and issue monthly expediting report, following the guidelines of the OM/E procedure. Expeditor will maintain the records for issue and acknowledgment for MDR’s The expeditor shall initiate for PIM / PMM in consultation with inspector and Vendor/Supplier. ___________________ Are you a MATCH? Required Qualifications And Competencies Education: Masters/Bachelor Degree Discipline Engineering Additional contractual / commercial / Supply Chain Management education/ qualification may be an added advantage Experience - 05 - 10 Years Industry - Oil & Gas / Petrochemical / EPC Knowledge in ERP / SAP Language: Fluent in English Our Differences make our Performance At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world. We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world. Show more Show less

We are looking for an entry-level Splunk Associate to support our managed detection and response (MDR) operations. You’ll assist with log onboarding, dashboard creation, and incident correlation using Splunk. Key Responsibilities Work on Splunk data ingestion from various log sources (Windows, Linux, Firewall). Assist in building dashboards, alerts, and scheduled reports. Support troubleshooting of indexers, search heads, and source configurations. Document SOPs and queries for internal knowledge sharing. Requirements Basic understanding of Splunk or SIEM tools. Familiar with Linux/Windows system logs. Interest in cybersecurity, SOC operations, or log analytics. Splunk Fundamentals I certification is a plus. Show more Show less

To oversee and manage all aspects of the QMS to ensure compliance with global regulatory standards, including the CDSCO requirements. Job Location : Chamarajpet, Bengaluru.

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills. Show more Show less

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills. Show more Show less

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills. Show more Show less

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills. Show more Show less

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills. Show more Show less