299 Mdr Jobs - Page 3

Description Job Responsibilities: Lead the enterprise-wide security incident management and response. Review, evaluate, and enhance incident detection and response capabilities by periodic review of tools, processes, and IR playbooks. Ability to handle 24 * 7 operations with a hybrid operating model (In House + MDR) to gain the maximum efficiency and business benefits. Generating security metrics that align with business risks, reports, and dashboards for management consumption. Lead efforts to drive automation using SOAR of incident triage and response and expand advanced threat hunting capabilities. Provide functional direction and support for daily support activities. Develop and mentor staff through open communication, training, and development opportunities. Develop strategic goals to transform the Security operations center to be ready for the changing threat landscapes and evolving challenges. Required Skills Minimum 5 years of leading a Security team, with experience managing security incident detection and Response program. Creative thinker with exceptional business, strategic, analytical, management, and relationship management skills. Strong knowledge of networks, operating systems, cryptography, preventive, detective, and offensive security solutions. Experience working with cloud services like Amazon Web Services, Google, and Microsoft Azure Cloud Excellent understanding of information security concepts, protocols, tools, industry best practices, and strategies. Focus on a business appropriate measured response, strong time management, effective prioritization, and proper sense of urgency in day-to-day Security Operations. Ability to identify needs, take the initiative, and prioritize work efforts — balancing operational tasks with longer-term strategic security efforts. Experience in designing, implementing, and measuring relevant security and technology management critical success factors, key performance indicators, and metrics. Experience working with security detection/prevention platforms like EDR, Container Security, Identity product, Vulnerability Management products and process, Microsoft Security platforms, Data protection platforms, Threat/Brand Intel and Identity Intelligence, SIEM, SOAR platforms etc. Experience working with industry-standard forensics tools (X-Way forensics, Encase, Access data, SIFT, FTK) Excellent understanding & concept of standard audits such as PCI, SOC2, ISO27001, and SOX. Security certifications such as CISSP. Show more Show less

Security Operations Center Manager will be responsible for leading Envestnet Security Incident response program by ensuring an appropriate, riskbased approach for SecurityMonitoring/Incident detection, Security Incident Response and Remediation process by partnering with MDR (Managed Detection and Response) service and internal teams. This will be accomplished through the effective functional management of day today tasks of securityanalysts, third party MDR provider, Implementations and maintenance of processs, and deployed security tools for detection, prevention, and response. Job Responsibilities: Lead the enterprise-wide security incident management and response. Review, evaluate, and enhance incident detection and response capabilities by periodic review of tools, processes, and IR playbooks. Ability to handle 24 * 7 operations with a hybrid operating model (In House + MDR) to gain the maximum efficiency and business benefits. Generating security metrics that align with business risks, reports, and dashboards for management consumption. Lead efforts to drive automation using SOAR of incident triage and response and expand advanced threat hunting capabilities. Provide functional direction and support for daily support activities. Develop and mentor staff through open communication, training, and developmentopportunities. Develop strategic goals to transform the Security operations center to be ready for the changing threat landscapes and evolving challenges. Required Skills: Minimum 5 years of leading a Security team, with experience managing security incident detection and Response program. Creative thinker with exceptional business, strategic, analytical, management, and relationship management skills. Strong knowledge of networks, operating systems, cryptography, preventive,detective, and offensive security solutions. Experience working with cloud services like Amazon Web Services, Google, and Microsoft Azure Cloud Excellent understanding of information security concepts, protocols, tools, industry best practices, and strategies. Focus on a business appropriate measured response, strong time management, Effective prioritization, and proper sense of urgency in day-today Security Operations. Ability to identify needs, take the initiative, and prioritize work efforts — balancing operational tasks with longer-term strategic security efforts. Experience in designing, implementing, and measuring relevant security and technologymanagement critical success factors, key performance indicators, and metrics. Experience working with security detection/prevention platforms like EDR, ContainerSecurity, Identity product, Vulnerability Management products and process,MicrosoftSecurity platforms, Data protection platforms, Threat/Brand Intel and Identity Intelligence, SIEM, SOAR platforms etc. Experience working with industry-standard forensics tools (XWay forensics, Encase, Access data, SIFT, FTK) Excellent understanding & concept of standard audits such as PCI, SOC2, ISO27001, and SOX.Security certifications such as CISSP. Show more Show less

Job Title: Head – Quality Assurance & Regulatory Affairs (Medical Devices) Location: Visakhapatnam /Chennai Position Type: Full-Time Experience Level: Senior (Individual Contributor + Leadership Oversight) Reports To: CEO / COO / Head of Operations About the Role We are looking for a highly experienced and execution-driven QA/RA professional to lead our Quality and Regulatory function as we scale medical device manufacturing under FDA and EU MDR frameworks. This role is ideal for someone who combines deep regulatory expertise with a hands-on approach —someone who leads by doing, not just directing. You will be responsible for establishing and maintaining the entire Quality Management System (QMS) , ensuring regulatory compliance, and guiding the company through audits, certifications, and product registrations—while also being actively involved on the ground with documentation, process qualification, and compliance monitoring. Key Responsibilities Own and lead all aspects of Quality Assurance and Regulatory Affairs for medical device manufacturing and compliance Establish, implement, and maintain a fully compliant QMS aligned with ISO 13485 , FDA 21 CFR Part 820 , and EU MDR requirements Prepare and manage technical documentation , regulatory submissions , design dossiers , risk files , and CE/FDA pathways Act as the Management Representative for audits, inspections, and regulatory communications Lead internal audits , CAPAs , nonconformance investigations , and supplier qualification processes Oversee validation and qualification protocols (equipment, process, software) and ensure traceability and documentation control Guide the team through design transfer and ensure manufacturing readiness Develop and enforce quality culture across functions and teams Provide strategic regulatory guidance while staying actively involved in the execution of QA/RA tasks Qualifications Bachelor's or Master’s degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field 7–12 years of experience in medical device QA/RA , with at least 3+ years in a leadership role Proven track record of working with FDA (QSR) , ISO 13485 , and EU MDR frameworks Experience in leading regulatory submissions for 510(k), CE Marking, and ISO audits Strong documentation, technical writing, and compliance skills Comfortable being hands-on: writing procedures, reviewing records, attending floor-level quality issues Excellent communication and leadership skills; able to interface with auditors, regulators, and internal teams Experience in a start-up or scale-up manufacturing environment is a strong plus What We’re Looking For A doer and leader who takes ownership and drives outcomes Someone who can build and lead systems , but also get into the details when required A compliance-focused mindset with the practicality to operate in a dynamic environment Someone passionate about building safe, effective, and regulatory-compliant medical technologies To Apply: Please send your resume and a short note on your most relevant QA/RA leadership experience to hr@adiuvodiagnostics.com Job Type: Full-time Pay: ₹100,000.00 per month Benefits: Provident Fund Schedule: Day shift Weekend availability Ability to commute/relocate: Vishakapatnam, Andhra Pradesh: Reliably commute or planning to relocate before starting work (Preferred) Work Location: In person Expected Start Date: 01/07/2025

Job Description Experienced leader to oversee Medical Device Vigilance and Safety services. This role will be responsible for developing and implementing pre- and post-market surveillance (PMS) strategies, ensuring compliance with global regulations, and managing safety reporting for our medical device portfolio. Key Responsibilities Develop and implement medical device vigilance strategies aligned with regulatory requirements Ensure compliance with global regulations for medical devices, including EU MDR, FDA, and other market requirements Overall management of individual case safety reports (ICSRs) and medical device reports (MDRs) / post-market surveillance activities Direct preparation and review of Periodic safety update reports (PSURs), Clinical evaluation reports (CERs) and other regulatory submissions Lead discussions with notified bodies and regulatory authorities on safety data for medical devices / drug-device combination products, as applicable Manage a unit of medical device safety professionals, including implementing training programs Collaborate with cross-functional teams (Clinical Affairs, Quality Assurance, Regulatory Affairs) on safety strategies and product development Oversee risk management plans and benefit-risk assessments for medical devices Leverage data analytics for signal detection and trend analysis in medical device safety Contribute to long-term strategic planning for device safety activities Qualifications Advanced degree in Life Sciences, Pharmacy, Medicine, Medical devices or related field Minimum 8 years of experience in PMS / medical device vigilance, with at least 5 years in a leadership role Extensive knowledge of global medical device regulations, particularly EU MDR and FDA requirements Strong understanding of medical device vigilance processes and best practices Show more Show less

Job Title: Product Safety Risk Management Specialist Job Summary: We are seeking a detail-oriented professional to take ownership of product safety risk management activities throughout the product lifecycle. This role is responsible for ensuring compliance with ISO 14971 and other applicable standards and regulations, maintaining Risk Management Files, and continuously monitoring product safety in the field. Key Responsibilities: Develop and maintain Risk Management Files during product development and lifecycle per ISO 14971 and relevant product-specific regulations. Monitor and report on product safety performance in the field, ensuring timely updates to risk documents. Assess process and product changes to determine their impact on existing Risk Management documentation. Evaluate post-market surveillance data (e.g., complaints, CAPA, NCRs, customer feedback) for implications on risk assessments and documentation. Required Skills & Experience: Strong knowledge of ISO 14971, FDA 21 CFR 820, EU MDR, IEC 60601-1, IEC 62304, and IEC 62366-1. Hands-on experience with risk analysis methodologies such as FMEA. Proven track record in developing and maintaining risk management deliverables. Strong interpersonal and influencing skills. Clinical knowledge is a plus. Show more Show less

Job Title : Presales Lead Job Location: Mumbai (Thane/Andheri) Job Purpose: The Presales Lead will drive cybersecurity solutioning, customer engagement, and sales enablement across MDR/CES/MSSP services. They must have strong expertise in security technologies (SIEM, EDR, firewalls, cloud security) and IT infrastructure. Responsibilities include responding to RFPs, conducting PoCs, crafting proposals, and engaging with C-level executives. Strong consultative selling, presentation, and negotiation skills are essential. The role requires collaboration with sales, technical, and product teams, along with CRM proficiency. Roles & Responsibilities 1. Solutioning & Technical Expertise Understand customer security needs and design tailored cybersecurity solutions across MDR/CES/MSSP services. Conduct Proof of Concepts (PoCs), product demos, and technical workshops to showcase solutions. Stay updated on cybersecurity trends and technologies (SIEM, SOAR, XDR, Cloud Security, IAM/PAM, Firewalls, Endpoint Security, Threat Intelligence). 2. RFP/RFI & Proposal Management Lead technical responses to RFPs/RFIs, ensuring high-quality proposal submissions. Develop and present compelling business cases, solution architectures, and value propositions for clients. Work with internal teams to create pricing models, service offerings, and customized solutions based on client needs. 3. Sales & Customer Engagement Engage with C-level executives, IT teams, and security stakeholders to drive technical discussions. Act as a trusted advisor , translating complex cybersecurity concepts into business-friendly solutions. Support the sales team in deal closure by addressing objections, defining technical scopes, and guiding the sales cycle. 4. Market Intelligence & Competitive Analysis Analyze competitor offerings, industry trends, and emerging threats to refine presales strategies. Collaborate with marketing and product teams to enhance solution messaging and positioning. Identify upselling and cross-selling opportunities by aligning solutions with customer business goals. 5. Internal & Cross-Functional Collaboration Work closely with the delivery, technical, and product teams to ensure seamless solution deployment. Train and enable sales teams on cybersecurity products, services, and market differentiators . Maintain accurate pipeline tracking and reporting using CRM tools (Salesforce, HubSpot, Zoho, etc.) . Skills / Certificates Required: The Presales Lead should have expertise in cloud security (AWS, Azure, GCP), Zero Trust, IAM, PAM, and SOC operations, along with knowledge of automation (SOAR, XDR) and AI-driven threat detection. Strong business acumen, leadership, and stakeholder management skills are essential. Preferred certifications include AWS Security, SC-900, CISA, CRISC, OSCP, GPEN, and ITIL or PMP for project management. Experience with SIEM tools like Splunk and QRadar is a plus. The role requires a strategic mindset, problem-solving skills, and the ability to assess security investments and ROI while aligning cybersecurity solutions with business needs. Experience: 4+ years in a pre-sales or solution consulting role, preferably in MDR, MSSP, CES, or cybersecurity services. Show more Show less

Job Description Job Overview: The Civil/Structural Designer provides solutions to problems in the Civil/Structural Design discipline without supervisory approval and will evaluate and select solutions from established operating procedures and/or scientific procedures. Responsibilities Key Tasks and Responsibilities: Prepare and develop arrangement and detail design drawings of high technical quality and professional consistent presentation, ensuring clarity and ease of construction Develop 3D models Ensure work complies with MDR and project QA and/or QC systems and procedures Apply basic technical skills and knowledge to complete assigned work Continue developing skills to efficiently complete repetitive tasks Manage own time to meet deadlines set by others Become fully familiar with the Project Scope of Work, specifications, schedule, and inter-discipline requirements, including identifying concerns as early as practicable and taking appropriate initiatives to address them Prepare Civil and Structural layouts from data generated by others, in close liaison with Civil and Structural Engineers and counterparts from other disciplines Ensure that the work is carried out in accordance with McDermott requirements, Client and Statutory Design Codes, Standards, or Procedures with a particular focus on Health and Safety Policies Develop 3D Models and ensure clash free model in coordination with all other disciplines' requirements Organize own design work Check designs, with particular emphasis on interfaces with other disciplines Provide drafting support as required Review other discipline drawings Review supplier drawings Reports To: Project: Lead Designer, Lead Engineer Functional: Supervising Department Manager Liaise With: Engineers, other Designers, and Senior Designers Supervises: Associate Designers Qualifications Essential Qualifications and Education: High School graduate with a diploma in Civil or Structural disciplines or equivalent experience 3 years minimum with a major contractor or consultant Knowledge of associated industry detailing standards Knowledge of 2D and/or 3D drafting systems (AutoCAD and/or MicroStation) Knowledge of E3D and/or S3D Knowledge of AutoCAD and/or Auto lisp Programming, 3D Modeling, and 2D Drafting Menu and/or Macro compilation skills Eager to learn Working knowledge of English, both oral and written HSE, TQM, and cost-conscious Show flexibility and ensure proper hand-over with regards to: The reassignment to other departments, construction sites, and fabrication yards The replacement of colleagues during illness and holidays The provision of assistance to other colleagues with heavy workloads (also other projects) when possible/desirable The managing/learning of future current working methods and software applications Is familiar with the use of codes and standards 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

Job Description Job Overview: The Civil/Structural Designer provides solutions to problems in the Civil/Structural Design discipline without supervisory approval and will evaluate and select solutions from established operating procedures and/or scientific procedures. Responsibilities Key Tasks and Responsibilities: Prepare and develop arrangement and detail design drawings of high technical quality and professional consistent presentation, ensuring clarity and ease of construction Develop 3D models Ensure work complies with MDR and project QA and/or QC systems and procedures Apply basic technical skills and knowledge to complete assigned work Continue developing skills to efficiently complete repetitive tasks Manage own time to meet deadlines set by others Become fully familiar with the Project Scope of Work, specifications, schedule, and inter-discipline requirements, including identifying concerns as early as practicable and taking appropriate initiatives to address them Prepare Civil and Structural layouts from data generated by others, in close liaison with Civil and Structural Engineers and counterparts from other disciplines Ensure that the work is carried out in accordance with McDermott requirements, Client and Statutory Design Codes, Standards, or Procedures with a particular focus on Health and Safety Policies Develop 3D Models and ensure clash free model in coordination with all other disciplines' requirements Organize own design work Check designs, with particular emphasis on interfaces with other disciplines Provide drafting support as required Review other discipline drawings Review supplier drawings Reports To: Project: Lead Designer, Lead Engineer Functional: Supervising Department Manager Liaise With: Engineers, other Designers, and Senior Designers Supervises: Associate Designers Qualifications Essential Qualifications and Education: High School graduate with a diploma in Civil or Structural disciplines or equivalent experience 3 years minimum with a major contractor or consultant Knowledge of associated industry detailing standards Knowledge of 2D and/or 3D drafting systems (AutoCAD and/or MicroStation) Knowledge of E3D and/or S3D Knowledge of AutoCAD and/or Auto lisp Programming, 3D Modeling, and 2D Drafting Menu and/or Macro compilation skills Eager to learn Working knowledge of English, both oral and written HSE, TQM, and cost-conscious Show flexibility and ensure proper hand-over with regards to: The reassignment to other departments, construction sites, and fabrication yards The replacement of colleagues during illness and holidays The provision of assistance to other colleagues with heavy workloads (also other projects) when possible/desirable The managing/learning of future current working methods and software applications Is familiar with the use of codes and standards 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

Job Overview JOB DESCRIPTION The Senior Electrical Designer completes a variety of Electrical Design assignments as needed and can complete work with a limited degree of supervision. They are an informal resource for colleagues with less Electrical Design experience. They developed proficiency in a range of analytical processes or procedures to carry out assigned tasks. They provide solutions to problems in situations that are atypical or infrequently occurring based on existing precedents or procedures. The Senior Electrical Designer directly impacts the quality of the work of the team. Responsibilities Key Tasks and Responsibilities Prepare and develop arrangement and detail conceptual, FEED, studies, and detail design drawings of high technical quality and professional consistent presentation ensuring clarity and ease of construction Develop 3D models and ensure clash-free with all other disciplines Ensure design deliverables are completed and issued per project specifications, MDR, and project Level 2 & 3 procedures, and within agreed schedules Apply knowledge and/or skills to complete a variety of day-to-day activities within own area Continue developing skills to complete repetitive tasks efficiently Prioritize and organize own work to meet agreed-upon deadlines Become fully familiar with the Contract 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 notification in the Change Management system, including providing any necessary supporting documentation and estimates Provide similar support for Variation Orders Interface with all disciplines to develop clash-free designs Interface with other disciplines to obtain input for Discipline designs and drawings Liaise with other discipline support groups to ensure clearly defined interfaces, deliverables, and schedules are met Document substantive communications (communications that result in significant decisions or assignment of actions), and forward copies to Discipline Lead Designer and Discipline Supervisor Assist Discipline Lead Designer in preparing estimates for proposals and job scope changes, including execution statements, work schedules, and man-hour requirements Raise technical queries to obtain missing information, clarify work scope, and maintain preferred McDermott procedures, specifications, standards, practices, and operational requirements Participate in finalizing deliverables lists, deliverables, and philosophies to ensure compliance with specifications and functional integrity Attend project kickoff and review meetings, vendor/supplier meetings, engineering and design meetings, and offshore site surveys as required Research Customer standards and procedures in order to prepare project-specific design procedures and standards for submission to the Customer for approval Set up and maintain the Discipline Master design drawing and document files, including final archiving Prepare and review Discipline deliverables such as: 3D model Detailed design drawings As-built drawings Review drawings issued by other disciplines and incorporate the required data into Discipline drawings Review vendor drawings and documents and incorporate required vendor data into Discipline drawings and documents Assist in providing necessary design inputs to other disciplines to enable them to proceed with their deliverables Identify all items for which insufficient data is available to allow the drawing or model to be completed (HOLDS), and list these on the drawing and on the standard 'HOLDS' list form Notify the Discipline Lead Designer when there are updates to the Holds list Generate IDC design documentation for the project Perform design verification through single discipline checks (SDC) and/or inter-discipline checks (IDC), providing comments to the Lead Designer Review all project IDC design documentation for detailed technical interfaces Maintain single discipline and inter-discipline check drawings and filing Prepare, issue, and update material and weight data take-offs Assist Fabrication as required in the resolution of construction difficulties relating to design problems, clashes, etc. Monitor progress and maintain the Discipline deliverables register on an ongoing basis Ensure compliance with the Project Execution Plan and the timely completion and archiving of drawings and documents Keep the Lead Designer apprised of all activities, progress, and concerns, including manpower and budgetary-related Assist in providing inputs for actual, planning, and forecasting progress reports including associated productivity Report errors and suggest resolution for the same Participate in design reviews and audits Capture lessons learned and enter into MDR's Lessons Learned system Guide less experienced Designers on MDR and Discipline procedures, standards, worksheets, design calculations, software, technical queries, etc. Provide guidance to trainee Designers Assist in the maintenance of departmental technical guidelines and standards Further develop an understanding of MDR's business including processes and procedures Prepare/review Electrical Design deliverables such as: 3D model Electrical scopes One-line diagrams Schematics Interconnection and wiring diagrams Block diagrams Area classification drawings Conduit and cable schedules Power layout drawings Earthing/grounding layout drawings Lighting layout drawings Electrical cable tray drawings Electrical building drawings Electrical support drawings Electrical drawing indexes Lighting design calculations Cable sizing Prepare/review bills of material and perform material take-offs for electrical items including cables, lighting fixtures, cable trays, cable glands, termination kits, and MCTs Participate in clash resolution meetings, as required Travel to the fabrication yard to assist in mechanical completion, hookup, and/or commissioning, as required Reports to: Project: Lead Designer Functional: Supervising Designer or Engineering Manager Liaise With: Electrical Engineers, other Electrical Designers, the Lead Designer, and assigned designers in other disciplines Supervises: Assigned Designers and trainee designers Qualifications Essential Qualifications and Education High School graduate with a diploma in Civil, Electrical, or Mechanical Design, or Drafting in a related discipline or equivalent experience 6 years min with major contractor or consultant of which 2+ years of experience in oil and gas Detailed knowledge of associated industry detailing standards Detailed knowledge of 3D and 2D drafting systems (AutoCAD and/or MicroStation) Working experience in E3D and/or S3D Knowledge of QA Systems and a good communicator Detailed knowledge of AutoCAD and/or Auto lisp Programming, 3D Model creation, Menu and/or Macro compilation skills would be an advantage 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

Civil engineer with 10-15 yrs working experience in Infrastructure Projects and required sound in Project planning, coordination, execution, and ensuring successful completion while adhering to technical specifications, budgets, billing and timelines. Manage resources, maintain project standards, problem solving, quality control and ensure compliance with relevant regulations. Candidate should be minimum 5 years road work (ODR/MDR/SH/NH) experienced. Flexible and rigid pavement road work experienced candidate preferable. Job Types: Full-time, Permanent Pay: ₹480,000.00 - ₹600,000.00 per year Benefits: Cell phone reimbursement Food provided Internet reimbursement Leave encashment Life insurance Provident Fund Schedule: Day shift Work Location: In person Application Deadline: 17/06/2025 Expected Start Date: 11/06/2025

Role Description Job Title: L1 SOC Analyst Experience : 2 to 3 years Location: Trivandrum, Kochi, Chennai, Bangalore, Hyderabad Company: CyberProof, A UST Company About CyberProof CyberProof is a leading cyber security services and platform company dedicated to helping customers react faster and smarter to security threats. We enable enterprises to create and maintain secure digital ecosystems through automation, threat detection, and rapid incident response. As part of the UST family, we are trusted by some of the world’s largest enterprises. Our Security Operations Group is composed of a global team of highly skilled cyber security professionals, with our tier 3-4 expertise rooted in Israeli Intelligence. The primary role of a SOC Level 1 Analyst is to serve as the frontline defense, managing first triage and ranking of security cases, and initiating the threat detection and response processes for client-related security events. The Analyst is integral to the MDR, working collaboratively with other teams to ensure high quality of service, and will be given opportunities for professional growth in cybersecurity. The position entails conducting inquiry procedures as dictated by CyberProof methodology and contributing insights on the case investigation and detection quality. Principal Duties Quickly respond to and classify all incoming security cases, ensuring that incidents are appropriately escalated to the right analyst within the predefined SLA period during the Analyst's shift. Conduct the first triage investigations into the assigned cases using a blended approach based on tools integrated into the SOAR platform and document all collected evidence and conclusions. At the shift's commencement, diligently review all new information in the SOAR, through the Teams channel, shared mailbox, and any other designated communication mediums to ensure readiness to continue or start case the investigation and address client queries. Facilitate a smooth handoff to the next team at the end of the shift, ensuring continuous and seamless security monitoring. Remain to any procedural inconsistencies or issues and proactively report these to the team leader or upper analytical layer (L2) for resolution or consultation. Should uncertainty or complex issues arise, elevate the matter promptly to a senior L1 Analyst or Shift and Technical Leads before resorting to the L2 team. Support the Lead Analysts and the L2 team in the extraction and compilation of data needed for the preparation of Weekly, Monthly, and Quarterly Business Review (QBR) documentation. Skills And Qualifications At least 1 year of experience as a security analyst Proficient in investigating s related to phishing, malware, and similar threats. Solid understanding of computer security and networking concepts Experience with SIEM or similar security tools (Splunk or Qradar or Sentinel). Knowledgeable about endpoint protection tools Skilled in analyzing network traffic, interpreting logs, and examining packet capture. Strong critical thinking and analytical abilities Excellent written and verbal communication skills Experience managing and analyzing s from security tools is a plus. Familiarity with cloud solutions is advantageous. Relevant certifications are a plus. Show more Show less

Key Responsibilities: Project Delivery & Oversight Lead end-to-end delivery of MedTech projects, including software platforms, connected devices, and digital health tools. Define project scope, goals, and deliverables in collaboration with stakeholders. Manage timelines, budgets, and resource allocation. Stakeholder Management Act as the primary liaison between clinical teams, IT, vendors, and regulatory bodies. Translate clinical and business requirements into technical specifications. Compliance & Quality Ensure all solutions comply with healthcare regulations (e.g., FDA, MDR, HIPAA). Oversee validation, testing, and documentation processes. Team Leadership Lead cross-functional teams including developers, QA, clinical informaticists, and product managers. Mentor junior team members and foster a culture of continuous improvement. Risk & Issue Management Identify project risks and develop mitigation strategies. Resolve delivery issues and escalate when necessary. Qualifications: Bachelor's or Master's degree in Engineering, Computer Science, Biomedical Engineering, or related field. 5+ years of experience in project or delivery management within the MedTech, HealthTech, or Life Sciences sector. Strong understanding of medical device lifecycle, software development (SDLC), and regulatory frameworks. Experience with Agile, Scrum, or hybrid project methodologies. Excellent communication, leadership, and stakeholder management skills.

Education: B.E Mechanical/Bio-Medical Experience: 2.5 to 5 yrs Knowledge on Medical device regulations Good Communication skills Ability to read through the Medical Device Documents Ability to work on Microsoft tools (Excel, Word and PowerPoint) Experience on Medical Device UDI Data management will be additional preference.

About OrthoHeal: OrthoHeal is a leading MedTech innovation company committed to transforming orthopedic care through cutting-edge technologies and advanced immobilization solutions. With a growing global footprint, we design, manufacture, and deliver orthopedic products that enhance patient comfort, recovery, and outcomes. Position Overview: We are seeking a proactive and detail-oriented CRM Manager to lead our customer relationship management initiatives at the Manjusar plant. The ideal candidate will play a key role in maintaining strong customer relationships, streamlining communication workflows, and ensuring customer satisfaction across domestic and international markets. This role involves close collaboration with cross-functional teams to support sales growth and retention. Key Responsibilities: ∙ Oversee the end-to-end use of the CRM platform to track and manage customer interactions. ∙ Develop and implement CRM strategies to enhance customer engagement, retention, and lifetime value. ∙ Work closely with the sales and customer service teams to ensure seamless lead and client data flow. ∙ Monitor and maintain data integrity within the CRM; ensure accurate and up-to-date customer profiles. ∙ Segment customer data and design targeted communication and marketing campaigns. ∙ Create regular performance and engagement reports for leadership using CRM analytics. ∙ Lead automation of key customer lifecycle touchpoints including onboarding, feedback, and re-engagement. ∙ Support domestic and international sales teams with CRM-driven insights and tools. ∙ Train internal stakeholders on CRM usage and best practices. ∙ Coordinate with IT and external vendors to enhance CRM functionalities as needed. Qualifications ∙ Bachelor’s or Master’s degree in Business Administration, Marketing, or a related field. ∙ 4–6 years of experience in CRM management, preferably in manufacturing or medical devices. Skills: ∙ Proficient in CRM tools such as Zoho CRM, Salesforce, or equivalent platforms. ∙ Strong analytical mindset with experience in handling large datasets. ∙ Excellent communication and collaboration skills. ∙ Ability to multitask in a fast-paced, team-oriented environment. ∙ Knowledge of customer journey mapping and campaign automation.  Preferred: ∙ Experience in medical device industry or B2B healthcare market. ∙ Familiarity with compliance standards in healthcare (e.g., MDR, ISO 13485). ∙ Certification in CRM platforms (e.g., Zoho CRM Admin, Salesforce Admin). Show more Show less

I. Key Responsibilities : Responsibility for the In Process Quality Control related activities are as under. · Daily/Weekly tracking of MDR/NQC at cell and sector levels. · Monitoring and updation of Cp/Cpk for critical processes. · Drive FMEA alongwith CFT for current and new processes · Perform RCA workshops along with CFTs for top contributors in MDR/PRR/NQC on weekly basis. · Periodic validation of all PY/JD implemented through PQCP/PFMEA are in good working conditions. · Ensure no deviation in methods/processes in assembly lines. · Addressing line issues as soon as they occur and ensure timely response. · Responsible for containment and corrective actions for all field and inhouse failures (PRR/MDR/NQC/line issues). · SPOC for Daily/weekly/monthly Quality MIS. · Responsible for Calibration of all measuring instruments. · Implement and maintain IMS for Quality · Responsible for Directive 32 implementation and follow up (Line audits) · Weekly review with stakeholders to line up actions for critical issues found in PRR/MDR/NQC/Line audits. · Workload management of line quality leaders. · SPOC for certification audits like CCC, UL, Global, Etc… · Escalate critical line issues to process robustness team on weekly basis and get the actions to implement where ever needed. · Update of Defect library accordingly Participate in field failure analysis and take necessary actions in the manufacturing line if the root cause is related to manufacturing. Surveillance / Reliability Test failure analysis Qualifications I. Background and Skill: · BE/BTech in Mechanical Engineering with Min 8 to 12 Years of experience in process and outgoing Quality Control in engineering / manufacturing industry. · Exposure to Welding (Resistance, MIG/TIG), assembly, torque, molding, stamping, electrical and mechanical testing processes). · Six sigma – Green Belt will be preferred · 8D / A3, Problem solving methodologies · GD&T, Inspection methodologies & Calibration · PFMEA & Control plan · Excellent communication, convincing & Presenting skills · ISO 9001:2015, TS-16949(Preferred Internal Auditor) · Well versed with Quality Module of SAP · Effective Team Management Schedule: Full-time Req: 008XXA Show more Show less

Come join Deepwatch’s team of world-class cybersecurity professionals and the brightest minds in the industry. If you're ready to challenge yourself with work that matters, then this is the place for you. We're redefining cybersecurity as one of the fastest growing companies in the U.S. – and we have a blast doing it! Who We Are Deepwatch is the leader in managed security services, protecting organizations from ever-increasing cyber threats 24/7/365. Powered by Deepwatch’s cloud-based security operations platform, Deepwatch provides the industry’s fastest, most comprehensive detection and automated response to cyber threats together with tailored guidance from dedicated experts to mitigate risk and measurably improve security posture. Hundreds of organizations, from Fortune 100 to mid-sized enterprises, trust Deepwatch to protect their business. Our core values drive everything we do at Deepwatch, including our approach to tackling tough cyber challenges. We seek out tenacious individuals who are passionate about solving complex problems and protecting our customers. At Deepwatch, every decision, process, and hire is made with a focus on improving our cybersecurity solutions and delivering an exceptional experience for our customers. By embracing our values, we create a culture of excellence that is dedicated to empowering our team members to explore their potential, expand their skill sets, and achieve their career aspirations, which is supported by our unique annual professional development benefit. Deepwatch Recognition Includes 2025, 2024, 2023, 2022 and 2021 Great Place to Work® Certified 2024 Military Times Best for Vets Employers 2024 US Department of Labor Hire Vets Gold Award 2024 Forbes' America's Best Startup Employers 2024 Cyber Defense Magazine, Global Infosec Awards 2023 and 2022 Fortress Cybersecurity Award 2023 $180M Series C investment from Springcoast Capital Partners, Splunk Ventures, and Vista Credit Partners of Vista Equity Partners 2022 Cybersecurity Excellence Award for MDR Our Backend Developer will report to the Manager , Detection Platform and will join a team of extremely technical individuals with a focus on handling complex issues, solving time-sensitive problems, and delivering robust solutions to Deepwatch. You will contribute to the planning, design, development, and maintenance of internal tools and detection platforms. Come join a highly collaborative development team building capabilities to deploy detections at scale. As a member , you will contribute to our mission to empower Deepwatch's customers to confidently defend their environments by deploying resilient detection platforms. As a Backend Developer , you will build tools that support internal workflows and deliver defensive capabilities to our customers. In This Role, You’ll Get To Develop internal tools to support and optimize workflows that lead to consistent results Develop product features, including gathering data that powers the Deepwatch Platform Write highly reusable code along with associated unit testing and end-to-end testing and contribute to software architecture design Develop integrations with security tools (e.g., EDRs, SIEMs, Ticketing Systems, Threat Intelligence Feeds) Learn and advance your career in a fast-changing industry , leveraging the company’s unique professional development benefits and matching policies to support our growth To be successful in this role, you’ll need to: Demonstrate programming proficiency in Python, Go, or Node.js Possess a solid understanding of object-oriented programming and knowledge building out either REST or GraphQL APIs with automated unit testing and knowledge of microservices architecture Have a good working knowledge of relational databases such as MySQL, PostgreSQL, MongoDB Have a good understanding of what ORM is and what it does Have a good understanding of authentication, security , caching, and testing principles Possess familiarity with version control systems such as git Possess familiarity with CI/CD processes and tools Have a good working knowledge of containerization such as Kubernetes and Docker Possess familiarity with search engines such as Elasticsearch Possess experience with Infrastructure as Code (IaC) such as Terraform Possess experience with configuration management/automation such as Ansible Be familiar with agile development processes and test-driven development Be familiar with secure coding standards such as OWASP and be willing to adapt to best practices Be self-driven, hold yourself accountable for outcomes, and manage your own time working in a flexible and remote-first environment Preferred Skills Understanding of log analysis, alert triage workflows, and incident response playbooks Experience integrating with or building components for SOAR and Data Lake platforms Life At Deepwatch For employees, Deepwatch fosters a unique, flexible work environment designed with collaboration in mind. The company emphasizes personal and professional growth, offering benefits such as professional development programs, comprehensive health coverage, and generous parental leave. Deepwatch is also committed to diversity, equity, inclusion, and belonging, aiming to empower underrepresented groups in tech by connecting them with meaningful opportunities, mentors, and sponsors. In recognition of its supportive workplace culture, Deepwatch earned the Great Place To Work Certification/(TM) in 2025, underscoring its dedication to creating a positive and inclusive work environment. Deepwatch is a global cybersecurity company with offices in San Francisco Bay Area, CA; Tampa, Florida; and Bengaluru, India. What We Offer At Deepwatch, we are committed to supporting our employees with a comprehensive benefits package designed to enhance your well-being and financial security. We Partner With Plum Benefits To Provide ✔ Group Health Insurance – Comprehensive medical coverage for you and your dependents. ✔ Group Accidental Insurance – Financial protection in case of accidental injuries. ✔ Group Term Life Insurance – Security for your loved ones in unforeseen circumstances. For additional details, refer to the benefits guide provided by Plum. Payroll & Compensation ✔ Pay Cycle: Salaries are processed monthly and paid on the last day of each month. ✔ Pay Slips & Reimbursements: Delivered via email. ✔ Payroll Processing: Managed by BCL Chartered Accountants through GreytHR, which provides tax and payment-related details. Show more Show less

URGENT OPENING Currently We required Manager - regulatory Affairs for Medical Device company. JD-Manager- Regulatory Affairs Plant office - Medical devices 52-54,63&64, Roz ka meo , Industrial Area, Nuh , District. Mewat ( Haryana), India Company will provide you the cab facility from Fix point of Gurugram & Faridabad Working Daya - 6 days in a week The candidate Profile and the job description is as follows - · The Company has state of art manufacturing facility and its own R & D facility with 10,000 and 1,00,000 Class room specifications with continuous innovations and thereby offering customized products as per the requirements of various markets in India and abroad. · The Company is accredited with the following standards – a) ISO 9001 : 2008 b) ISO 13485 : 2003 ( EN) c) Directive 93/42/EEC (CE) d) Registration certificate with Dept of Health & Human Services, USA e) GMP Certificate as per schedule M. f) DGQA registered · The Company is having strong presence in almost all the Corporate Hospitals across India besides Trade, Military, Para-Military forces and in prestigious Government institutions. · The Company markets under its own brand name in International markets like UAE, Oman, Sri Lanka, Nepal and Bangladesh and besides being an OEM supplier to various MNCs for the entire Europe, Australia, New Zealand, South Africa etc. · Company’s product range includes various types of high quality gauze and bandage products besides some unique products in the Advance Wound Care segment which are being exported to major companies in Europe as well as to Australia, New Zealand, Middle & Far East and South Africa. Key responsibilities: Spearheaded regulatory submission strategy for CE marking under EU MDR for Class IIa, IIb & III devices. Authored and maintained FDA 510 (K) submission, including predicate device comparison and labeling review. Developed and maintained Technical Files and Design Dossier for European markets. Coordinated Clinical Evaluation Reports (CER) and Periodic Safety Update Reports (PSUR). Acted as point-of-contact for notified bodies and regulatory authorities during audits and inspections. Implemented and maintained ISO 13485:2016-Compliant QMS, prepared company for successful MDSAP audit. Developed and maintained company-wide QMS in compliance with ISO 13485:2016 AND 21 CFR 820. Conducted risk management activities as per ISO 14971:2019 and ISO/TR 24971:2020, including, AFAP, FMEA and Hazard Analysis. Led PMS activity (Plan, Report and arrange the feedback, sales data and other regulatory requirements from Marketing team). Prepare documents related to the Post Market Surveillance, General Safety and Performance Requirement (GSPR) Risk Management process of Class III medical devices as per MDR 2017. Plz Mention your Current CTC - Expected CTC - Notice period- Date of Birth- And ready for relocate - Regards, Khushi Asthana HR Manager Pratham Search Job Types: Full-time, Permanent Pay: ₹70,000.00 - ₹100,000.00 per month Benefits: Cell phone reimbursement Food provided Health insurance Provident Fund Work Location: In person

Job Title: Senior SOC Analyst Department: IT Infrastructure Location: Bangalore / Coimbatore Job Type: Full-Time Experience: 7+ years Immediate joiners or notice period of less than 30days are needed. Job Role: A Senior SOC Analyst is a cybersecurity professional responsible for proactively monitoring, analyzing, and responding to security threats within Logixhealth network and systems. They play a crucial role in detecting, investigating, and containing security incidents, as well as developing and improving security solutions. SOC 24/7, SOC monitoring Role Description: The analyst performs monitoring, research, assessment and analysis on Intrusion Detection and Prevention tools as well as Anomaly Detection systems, Firewalls, Antivirus systems, proxy devices (IPS IDS) which requires demonstrable security incident response experience. Perform initial risk assessment on new threats and vulnerabilities, perform assessment phase of Vulnerability and Threat Management process. Perform assessment as well as troubleshooting and help isolate issues with IDS/IPS sensors, Antivirus Cloud MS O365 Defender, Application monitor control, Mobile management (Intune), Vulnerability scanners Nessus professional ,Qualys PCI DSS scanners or other vulnerability Management tools. Patch management & MS O365 Defender Console monitoring. Participate in daily and ad-hoc conference calls as well as compliance and controls, self-assessment processes and documentation related tasks. Log and event management log monitoring and share the daily report. Exposure to User behavior analytics tools. MS Azure sentinel Vulnerability Management. Compliant / Non-Compliant (Devices) Management using Intune. Application control using MS Cloud App security. Working Knowledge of Taegis Secure works or any XDR/EDR/MDR Products Working Knowledge of Password management tools similar tool Bit warden Microsoft Purview and Entra (Azure AD Identity Management) working knowledge. Key Deliverables: Being Proactive and handling SOC Alerts Provide analysis and trending of security log data from a large number of heterogeneous security devices. Analyze and respond to previously undisclosed software and hardware vulnerabilities Zero Day Exploits Coordinate with Intel analysts on open source activities impacting SLTT governments. Integrate and share information with other analysts and other teams Compliance ISO 27001-2022 ,SOC 2 type 2,HIPAA,Hi-Trust Flexible, quick learning, willing to work 24/7 and rotational shifts. Senior Security analysts are expected to be on-call to respond to incidents that arise outside of business hours Monitor, Manage, Remediate (Vulnerability Management) Advise based Vulnerability advisories (CISA, MS-ISAC,USCERT) and escalate to respective teams. Other duties as assigned Independent worker Able to read and Analyze Counter Threat Intelligence Reports and suggest appropriate actions. Manage SIEM and On board devices and respond to Alerts and Analyze and remediate. Skills: Incident response, Security posture management vulnerability Management in Hybrid environment (Cloud and Onsite) Creating and managing security tools and policies in tools such as SIEM, EDR, and DLP, Exposure to Application vulnerability management, API security. Strong understanding of networking, operating systems, and security technologies. Ability to analyze data, identify patterns, and draw conclusions. Ability to investigate and resolve security incidents effectively. Ability to communicate technical information clearly and concisely with all stakeholders and advise appropriate action. Significant experience in security operations, incident response, and threat analysis. Identifying areas for improvement in security processes and tools. Developing and implementing new security solutions Using threat intelligence to identify and mitigate potential risks. Staying up-to-date on the latest cyber threats and attack vectors. Ability to lead Security Projects and Programs and drive towards closure and stakeholder satisfaction. Other skills: Excellent knowledge of Intrusion Detection (TCP/IP knowledge, and Cyber security), various operating systems (Windows, and web technologies (focusing on Internet security) Ability to read and understand packet level data Intrusion detection and prevention and Network Security Products (IDS/IPS, firewalls, etc) Host Security Products (HIPS, AV, scanners, XDR,EDR) Knowledge of threats and technologies effecting Web Application vulnerabilities and recent internet threats Exposure on Vulnerability assessment as well as penetration testing Preferred Certifications from EC-Council, GIAC, (ISC)² are preferred [CISSP, CEH, GCIA, CCNA-Security] Good knowledge of forensics and Log analysis. Incident response and remediation Knowledge of Playbooks. Qualification: Any degree/BE/B. Tech (computer science, Cybersecurity) with technical certification from EC-Council, GIAC, (ISC)² [CISSP, CEH, GCIA, CCSP, CCNA-Security] Show more Show less

HEALTHIUM MEDTECH LIMITED Healthium Medtech Limited is a global medtech company focused on products used in surgical, post-surgical and chronic care. Our vision is to deliver “Access to precision medtech for every patient, globally.” We operate across 90+ countries, focusing on Advanced Surgery, Arthroscopy, Advanced Wound Care and Infection Prevention areas with the following accreditations: We are amongst the 1 stAsian Companies to receive CE certification under the new EU-MDR normsfor ClassIII implants. 1 in 5 surgeries performed globally uses a Healthium product. World'slargest non-captive surgical needles manufacturer by volume. 4 th Largest sutures manufacturer globally. #1 Independent Indian Medical Devices Company in surgical consumables. Global presence across 80+ countries with 85+ patents[including pending applications] across US, Europe and India. Great Place to Work-Certified™ organization. Healthium has 7 manufacturing facilities with several global certifications and approvalslikeUS FDA, CE, ISO, TGA and we are proud to reiterate that our products are certified under the stringent new EU-MDR norms – which implies the highest safety and quality standards as a medical devicemanufacturer. Our productsafety and effectiveness aresubstantiatedby clinicalstudies acrosslarge number of patientsinvarioussurgeries. Job description: The Manager – Finance & Accounts is responsible for overseeing and managing the day-to-day operations of the accounting department. This role involves supervising the team, preparing financial statements, ensuring compliance with accounting standards, and assisting with audits. The Accounting Manager will play a key role in financial reporting, budgeting, and ensuring accurate and timely processing of financial data. Key Responsibilities: 1. Financial Reporting : - Prepare and oversee the preparation of monthly, quarterly, and annual financial statements in compliance with Indian Accounting Standards (Ind AS) or other applicable financial regulations. - Prepare monthly financial Statements (including cash Flow) for review by the reporting manager. - Ensure accurate and timely submission of financial reports to the reporting manager. - Manage the month-end and year-end closing process and provide necessary documentation for audits. - Maintaining accurate and organized financial records and documentation. - Assisting in the preparation of financial reports for internal and external stakeholders. 2. Financial Accounting: - Review, verify, and process incoming invoices for accuracy, completeness, and compliance with company policies. - Helping team with reconciliation of vendor / customer statements to resolve discrepancies and ensure accurate accounting. - Prepare treasury-related reports, including cash flow forecasts, liquidity analysis, and investment reports. 3. Accounts Payable & Receivable : - Oversee the accounts payable and accounts receivable processes, ensuring timely payment and collection of invoices. - Review and approve payments, ensuring proper documentation and adherence to company policies. 4. Internal Controls & Audit : - Implement and maintain robust internal controls to safeguard the company’s assets and ensure the accuracy of financial reporting. - Liaise with external auditors and provide all necessary documentation and information during audits. - Ensure compliance with local laws, accounting regulations, and company policies. 5. Cash Flow Management : - Monitor and manage the company’s cash flow to ensure liquidity and timely payment of liabilities. - Prepare cash flow projections and recommend cash management strategies. 6. Financial Analysis : - Provide financial analysis and insights to management on key performance indicators (KPIs) and financial trends. - Identify areas for cost control and operational efficiency improvements. 7. Budgeting & Forecasting : - Assist in preparing annual budgets and forecasts in coordination with other departments. - Monitor budget performance and suggest corrective actions if necessary. Technical Skills : Proficient in SAP S/4 HANA. Strong knowledge of Indian Accounting Standards (Ind AS), GST, and Income Tax Laws. Advanced MS Excel skills and MS Power Point. Soft Skills : Strong leadership and team management skills. Excellent communication and interpersonal skills to liaise with internal teams, auditors, and tax authorities. Analytical mindset with attention to detail. Ability to work under pressure and meet deadlines. Work Environment: Typically working in an office environment with standard working hours, though some flexibility may be required during month-end closing or audit periods. Show more Show less

Job Title: Staff AI Engineer - MLOps Company: Rapid7 Team: AI Center of Excellence Team Overview: Cross-functional team of Data Scientists and AI Engineers Mission: Leverage AI/ML to protect customer attack surfaces Partners with Detection and Response teams, including MDR Encourages creativity, collaboration, and research publication Uses 20+ years of threat analysis and growing patent portfolio Tech Stack: Cloud/Infra: AWS (SageMaker, Bedrock), EKS, Terraform Languages/Tools: Python, Jupyter, NumPy, Pandas, Scikit-learn ML Focus: Anomaly detection, unlabeled data Role Summary: Build and deploy ML production systems Manage end-to-end data pipelines and ensure data quality Implement ML guardrails and robust monitoring Deploy web apps and REST APIs with strong data security Share knowledge, mentor engineers, collaborate cross-functionally Embrace agile, iterative development Requirements: 8–12 years in Software Engineering (3+ in ML deployment on AWS) Strong in Python, Flask/FastAPI, API development Skilled in CI/CD, Docker, Kubernetes, MLOps, cloud AI tools Experience in data pre-processing, feature engineering, model monitoring Strong communication and documentation skills Collaborative mindset, growth-oriented problem-solving Preferred Qualifications: Experience with Java Background in the security industry Familiarity with AI/ML model operations, LLM experimentation Knowledge of model risk management (drift monitoring, hyperparameter tuning, registries) About Rapid7: Rapid7 is committed to securing the digital world through passion, collaboration, and innovation. With over 10,000 customers globally, it offers a dynamic, growth-focused workplace and tackles major cybersecurity challenges with diverse teams and a mission-driven approach. 4o Show more Show less

In this role, you will lead a Regulatory Affairs Team for our Magnetic Resonance Imaging (MRI) Business Unit, Bangalore & Pune. You will also be accountable for developing and deploying innovative, compliant regulatory strategies to grow and sustain the MRI portfolio. This portfolio spans imaging medical systems and software and drives Philips’ mission to improve the lives of 2.5 billion people by 2030. This position requires building and strengthening regulatory capabilities to drive, but not be limited to, software and AI applications and bring efficiencies through excellence in regulatory operations. This position reports to the Director of Regulatory Affairs, MRI Business Unit. Your role: Lead Regulatory Affairs team, from end to end (product inception through to lifecycle management), driving innovation, actively providing value-added regulatory affairs input and deliverables for new product introductions and product changes across the globe. Led the development and deployment of innovative Regulatory strategies with efficiency and compliance, bringing products to market and maintaining them compliantly to support business growth. This position will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW. Author and lead 510(k) submissions, pre-sub meetings, EU MDR Technical Documentation, and Health Canada license applications. Lead interactions with regulators/competent authorities throughout the review and approval process. Participate in strategic product development, design solutions from the concept phase to the product delivery phase, and provide regulatory guidance throughout design and development. Act as a Regulatory Subject Matter Expert on various aspects and provide strategic guidance to the other RA Staff and the project team. Able to manage special projects across the spectrum of product lines. Responsible for monitoring global regulatory landscapes and guiding cross-functional teams in implementing regulatory changes. Communicate new and upcoming changes and facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements. Review labelling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements. Identify areas for improvement in efficiency and compliance in internal processes, work instructions, and forms, and apply technical expertise to process improvement efforts. Lead or participate in process improvement teams to affect local or cross-business unit changes. Opportunity for mentoring and coaching other regulatory team members and providing regulatory guidance. Responsible for the hiring and developing critical talent within the Global Regulatory Affairs Team through creating and sustaining robust career & development plans, ongoing coaching and feedback, and identifying and addressing gaps in capabilities and competencies. Led and enabled strong cross-functional partnerships between Regulatory Affairs and all key stakeholders, including R&D, Marketing, Quality, Clinical Affairs, and other functions at all levels within the Business Unit. Building proactive, robust, strategic relationships with external stakeholders (FDA, NBs, CAs, MedTech forums, etc.) to influence and shape the external regulatory landscape across the domains relevant to the innovation agenda Providing critical input on regulatory risk assessments to support portfolio selection. You're the right fit if you have the following: A preferred candidate with a master's degree in engineering or a related field and a minimum of 10-12 years of experience in Regulatory Affairs in the medical device industry, with regulatory submission like 510(k), EU MDR Technical documentation, and global registration experience, is a must. (Experience with SaMD, AI, and digital health is a significant advantage.) Extensive experience and knowledge required of global medical device regulations, requirements, and standards 10 years of experience in people management, with a strong track record in successfully leading a Regulatory Affairs team Proven track record of leading in a matrix organization, leading cross-functional and diverse teams with challenging goals Experience with successful preparation and submission of Design Dossiers, 510(k), PMA, Technical /Design Dossiers, and international documents or registration of medical devices worldwide. Strong written, oral, and interpersonal skills required to lead a team as well as individual contributor. Solution- and detail-oriented, well-organized, self-motivated, and has the ability to negotiate with regulators. It may require up to 10% travel internationally per business needs. Show more Show less

URGENT OPENING Currently We required Manager - regulatory Affairs for Medical Device company. JD-Manager- Regulatory Affairs Plant office - Medical devices 52-54,63&64, Roz ka meo , Industrial Area, Nuh , District. Mewat ( Haryana), India Company will provide you the cab facility from Fix point of Gurugram & Faridabad Working Daya - 6 days in a week The candidate Profile and the job description is as follows - · The Company has state of art manufacturing facility and its own R & D facility with 10,000 and 1,00,000 Class room specifications with continuous innovations and thereby offering customized products as per the requirements of various markets in India and abroad. · The Company is accredited with the following standards – a) ISO 9001 : 2008 b) ISO 13485 : 2003 ( EN) c) Directive 93/42/EEC (CE) d) Registration certificate with Dept of Health & Human Services, USA e) GMP Certificate as per schedule M. f) DGQA registered · The Company is having strong presence in almost all the Corporate Hospitals across India besides Trade, Military, Para-Military forces and in prestigious Government institutions. · The Company markets under its own brand name in International markets like UAE, Oman, Sri Lanka, Nepal and Bangladesh and besides being an OEM supplier to various MNCs for the entire Europe, Australia, New Zealand, South Africa etc. · Company’s product range includes various types of high quality gauze and bandage products besides some unique products in the Advance Wound Care segment which are being exported to major companies in Europe as well as to Australia, New Zealand, Middle & Far East and South Africa. Key responsibilities: Spearheaded regulatory submission strategy for CE marking under EU MDR for Class IIa, IIb & III devices. Authored and maintained FDA 510 (K) submission, including predicate device comparison and labeling review. Developed and maintained Technical Files and Design Dossier for European markets. Coordinated Clinical Evaluation Reports (CER) and Periodic Safety Update Reports (PSUR). Acted as point-of-contact for notified bodies and regulatory authorities during audits and inspections. Implemented and maintained ISO 13485:2016-Compliant QMS, prepared company for successful MDSAP audit. Developed and maintained company-wide QMS in compliance with ISO 13485:2016 AND 21 CFR 820. Conducted risk management activities as per ISO 14971:2019 and ISO/TR 24971:2020, including, AFAP, FMEA and Hazard Analysis. Led PMS activity (Plan, Report and arrange the feedback, sales data and other regulatory requirements from Marketing team). Prepare documents related to the Post Market Surveillance, General Safety and Performance Requirement (GSPR) Risk Management process of Class III medical devices as per MDR 2017. Plz Mention your Current CTC - Expected CTC - Notice period- Date of Birth- And ready for relocate - Regards, Khushi Asthana HR Manager Pratham Search Job Types: Full-time, Permanent Pay: ₹70,000.00 - ₹100,000.00 per month Benefits: Cell phone reimbursement Food provided Health insurance Provident Fund Work Location: In person

Requisition Id : 1610020 As a global leader in assurance, tax, transaction and advisory services, we hire and develop the most passionate people in their field to help build a better working world. This starts with a culture that believes in giving you the training, opportunities and creative freedom. At EY, we don't just focus on who you are now, but who you can become. We believe that it’s your career and ‘It’s yours to build’ which means potential here is limitless and we'll provide you with motivating and fulfilling experiences throughout your career to help you on the path to becoming your best professional self. The opportunity : Consultant-National-Forensics-ASU - Forensics - Investigations & Compliance - Mumbai Your key responsibilities Technical Excellence Perform contract review, drafting and abstraction tasks Assist Client site contracts team- end to end contract lifecycle management (CLM) Handle different CLM processes i.e. including tool support, close-outs and legacy migrations, risk assessment and obligation management Support other MDR assignments, including forensic investigations, compliance and document review engagements Good written and verbal communication skills (English Language) Analytical bent of mind. Focused Target Oriented Skills and attributes To qualify for the role you must have Qualification Chartered Accountant with 1 year experience Experience Strong communication, presentation, facilitation, relationship-building and negotiation skills Be highly flexible, adaptable, and creative Willingness to travel to meet client needs What we look for People with the ability to work in a collaborative manner to provide services across multiple client departments while following the commercial and legal requirements. You will need a practical approach to solving issues and complex problems with the ability to deliver insightful and practical solutions. We look for people who are agile, curious, mindful and able to sustain postivie energy, while being adaptable and creative in their approach. What we offer With more than 200,000 clients, 300,000 people globally and 33,000 people in India, EY has become the strongest brand and the most attractive employer in our field, with market-leading growth over compete. Our people work side-by-side with market-leading entrepreneurs, game- changers, disruptors and visionaries. As an organisation, we are investing more time, technology and money, than ever before in skills and learning for our people. At EY, you will have a personalized Career Journey and also the chance to tap into the resources of our career frameworks to better know about your roles, skills and opportunities. EY is equally committed to being an inclusive employer and we strive to achieve the right balance for our people - enabling us to deliver excellent client service whilst allowing our people to build their career as well as focus on their wellbeing. If you can confidently demonstrate that you meet the criteria above, please contact us as soon as possible. Join us in building a better working world. Apply now.

Company Description Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait . We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets). ‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization. Job Description We are seeking a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations). This role will be responsible for developing and executing global regulatory strategies for combination product devices, ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. Qualifications 5+ years of regulatory affairs experience in biosimilars, biologics, or combination product development. Additional Information Provide regulatory guidance on device design, human factors, risk management, and manufacturing considerations. Lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. Ensure accurate regulatory documentation for design control, risk assessment, usability studies, and post-market surveillance. Work closely with R&D, Quality, Clinical, and Manufacturing teams to align regulatory strategies with product development. Support design verification and validation activities, including human factors engineering (HFE) and risk management. Provide regulatory support for product lifecycle management, including manufacturing changes, labeling updates, and device modifications. Show more Show less

Job Description Introduction: A Career at HARMAN Digital Transformation Solutions (DTS) We’re a global, multi-disciplinary team that’s putting the innovative power of technology to work and transforming tomorrow. At HARMAN DTS, you solve challenges by creating innovative solutions. Combine the physical and digital, making technology a more dynamic force to solve challenges and serve humanity’s needs Work at the convergence of cross channel UX, cloud, insightful data, IoT and mobility Empower companies to create new digital business models, enter new markets, and improve customer experiences About The Role We are seeking a dynamic and experienced Associate Director – Healthcare Projects to lead and manage large-scale healthcare and MedTech projects. The ideal candidate will have a proven track record in project delivery, cross-functional team leadership, and stakeholder management within regulated healthcare environments. What You Will Do Lead the successful delivery of complex healthcare and MedTech projects, ensuring alignment with business goals, timelines, and regulatory standards. Manage and mentor a large, cross-functional team of 30+ members including developers, QA, business analysts, and domain experts. Collaborate with internal and external stakeholders, including clients, product owners, and regulatory teams, to ensure project success. Drive project execution using Agile and Scrum methodologies, ensuring transparency, accountability, and continuous improvement. Oversee project planning, resource allocation, risk management, and budgeting across multiple healthcare domains. Ensure system integration between medical devices, cloud platforms, and web applications. Maintain strict adherence to regulatory and compliance requirements including HIPAA, FDA (21 CFR Part 820), and EU MDR. What You Need Minimum 5 years of project management experience with at least 10 years overall in the healthcare or MedTech industry. Proven experience managing large, multi-disciplinary teams (30+ members) in distributed or hybrid work environments. Strong understanding of system integrations involving medical devices and web platforms. Deep knowledge of regulatory frameworks including HIPAA, FDA, and EU MDR. Excellent communication, interpersonal, and leadership skills. Demonstrated ability to manage multiple stakeholders and align diverse teams toward common project goals. What Makes You Eligible You hold a Bachelor’s or Master’s degree in a relevant technical or healthcare domain. Minimum overall 15+ years of experience with at least 5 years in project management roles. Project Management certification (e.g., PMP, CSM, PMI-ACP) preferred. Proven exposure to cloud platforms, health data interoperability standards (like HL7, FHIR), and SaaS-based MedTech solutions. Demonstrated experience in handling regulatory compliance in healthcare IT projects. Strong ability to lead large, distributed teams in high-pressure, regulated environments while maintaining delivery excellence. What We Offer Access to employee discounts on world class HARMAN/Samsung products (JBL, Harman Kardon, AKG etc.) Professional development opportunities through HARMAN University’s business and leadership academies. Flexible work schedule with a culture encouraging work life integration and collaboration in a global environment. An inclusive and diverse work environment that fosters and encourages professional and personal development. Tuition reimbursement. “Be Brilliant” employee recognition and rewards program. You Belong Here HARMAN is committed to making every employee feel welcomed, valued, and empowered. No matter what role you play, we encourage you to share your ideas, voice your distinct perspective, and bring your whole self with you – all within a support-minded culture that celebrates what makes each of us unique. We also recognize that learning is a lifelong pursuit and want you to flourish. We proudly offer added opportunities for training, development, and continuing education, further empowering you to live the career you want. About HARMAN: Where Innovation Unleashes Next-Level Technology Ever since the 1920s, we’ve been amplifying the sense of sound. Today, that legacy endures, with integrated technology platforms that make the world smarter, safer, and more connected. Across automotive, lifestyle, and digital transformation solutions, we create innovative technologies that turn ordinary moments into extraordinary experiences. Our renowned automotive and lifestyle solutions can be found everywhere, from the music we play in our cars and homes to venues that feature today’s most sought-after performers, while our digital transformation solutions serve humanity by addressing the world’s ever-evolving needs and demands. Marketing our award-winning portfolio under 16 iconic brands, such as JBL, Mark Levinson, and Revel, we set ourselves apart by exceeding the highest engineering and design standards for our customers, our partners and each other. If you’re ready to innovate and do work that makes a lasting impact, join our talent community today! Show more Show less