918 Mdr Jobs - Page 31

Description INSLP (Security & Loss Prevention) is hiring an SLP Specialist to support growth of the “SLP MDR Concessions Abuse Program” and help preventing losses via identification of abusive entity. The program is aimed at identifying and eliminating Concessions Abuse while preserving customer trust. The primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction in accordance with INSLP guidelines and policies. The role is cross-functional and requires deep collaboration and influencing ability with stakeholders from business and corpo...

Job Description for Regulatory Affairs: Prepare and submit regulatory documentation for new and existing products. Monitor and interpret global regulatory requirements relevant to physiotherapy and medical equipment. Maintain regulatory compliance throughout the product lifecycle. Interface with regulatory agencies, notified bodies and external consultants. Ensure accurate and timely product registrations in target markets. Maintain up-to-date Device Master Files (DMF) and Technical Documentation. Support clinical evaluation and risk assessment documentation where required. Ensure products comply with applicable regulations, standards and guidelines Manage change notifications, renewals, ame...

1. University degree level or equivalent through experience and professional certification. 2. A minimum of 7-10 years in Security and Loss prevention role, law enforcement or security-related profession. 3. Extensive and up to date knowledge of Shrink management and Data Analysis. 4. Experience in managing or coordinating security investigations of complex nature. 5. Knowledge of information security processes and systems. 6. Experience in security auditing Job Description: The primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction ...

Company overview: TraceLink’s software solutions and Opus Platform help the pharmaceutical industry digitize their supply chain and enable greater compliance, visibility, and decision making. It reduces disruption to the supply of medicines to patients who need them, anywhere in the world. Founded in 2009 with the simple mission of protecting patients, today Tracelink has 8 offices, over 800 employees and more than 1300 customers in over 60 countries around the world. Our expanding product suite continues to protect patients and now also enhances multi-enterprise collaboration through innovative new applications such as MINT. Tracelink is recognized as an industry leader by Gartner and IDC, ...

Description Job Description: The primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction in accordance with India Security and Loss Prevention guidelines and policies. The role is cross-functional and requires deep collaboration and influencing ability with stakeholders from business and corporate functions. SLP Specialist's day-to-day activities involve planning, organizing, coordinating, implementing and executing process and procedures laid down by the organization and the SLP function. Identify the MDR shrink aspects last mile sta...

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. Develop project specific OM/E execution plan for ...

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Exe Date: Jun 2, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Job Objective Searching for highly motivated candidate having technical expertise in Biosimilar product analysis. Key Responsibilities: The candidate is expected to develop HPLC based methods for protein and peptide products. The candidate is expected to design and implement integrated strategies, linking appropriate analytical tools, to perform a...

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Manager 2 Date: May 15, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Development & Qualification of multiplex based cytokine release assay and Elispot/ flow cytometry based T cell assays to measure the innate and adaptive Immunogenicity of synthetic peptide products Job Responsibilities: Manage the study sample analysis for pipeline products, preparation of study schedule, design of experiments, trouble shoo...

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Executive Biotechnology Date: May 28, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd The candidate is expected to develop Surface Plasmon Resonance (SPR) based methods to measure the kinetic and equilibrium binding constants for protein and peptide products. Responsible for analytical method qualification for all pipeline products. Characterization of innovator product batches sourced from different geographic...

Job Requirements Mechanical Design Engineer (BE / Diploma in Mechanical or Equivalent) with 8-12 Years of experience Minimum 6 years’ experience in the medical device industry Hands-on experience in all phases of medical device life cycle (NPD, sustenance, post market support) Proficiency in Plastic, Sheetmetal and machined part design Part, sub-system and product level concept Design, Complete Engineering design Good knowledge of manufacturing processes Design for compliance with regulatory standards Regulatory standards knowledge like IEC 60601-1, MDR 2017/745 or MDR 2017/746, QSR per 21 CFR Part 820, particular standards, collateral standards, etc. Provide key inputs to the team, take pro...

Job Requirements Seeking a detail-oriented and experienced Technical Writer with a strong background in the medical domain. The candidate will be responsible for creating, editing and managing high quality documentation that meets regulatory and end-user needs. Develop, write and maintain clear and accurate documentation, including user manuals, technical specifications, training materials and regulatory documents. Collaborate with SMEs, product managers, software/ hardware, QA and regulatory teams to gather and validate information. Ensure all documentation complies with applicable medical device regulations and standards (eg: FDA, EU MDR, IEC 62304, IEC 60601 etc ) Maintain version control...

Job Requirements Mechanical Design Engineer (BE / Diploma in Mechanical or Equivalent) with 14+ Years of experience Minimum 8 years’ experience in the medical device industry Hands-on experience in all phases of medical device life cycle (NPD, sustenance, post market support) Develop Mechanical architecture for medical devices Proficiency in Plastic, Sheetmetal and machined part design Part, sub-system and product level concept Design, Complete Engineering design Good knowledge of manufacturing processes Design for compliance with regulatory standards Regulatory standards knowledge like IEC 60601-1, MDR 2017/745 or MDR 2017/746, QSR per 21 CFR Part 820, particular standards, collateral stand...

Job Description Job Overview: The Principal Electrical Engineer is responsible for interpreting internal or external business issues and recommending best practices. They will be tasked with solving complex Electrical-related problems and will work independently with minimal guidance. The Principal Electrical Engineer may be responsible for leading functional teams or projects and is regarded as a specialist in the field of Electrical. As such, they must have in-depth expertise in Electrical as well as broad knowledge of the Electrical discipline within the Engineering function. Responsibilities Key Tasks and Responsibilities: Become fully familiar with the project scope of work, specificati...

Head of Quality Assurance & Regulatory Affairs (QA/RA) Job Description As the In-charge of Quality Assurance and Regulatory Affairs (QA/RA), you will be a part of the executive team with the primary responsibility of building and maintaining Quality Systems. This role is strategically important for the success of commercialization goals, ensuring continuous improvement and high-quality products enter emerging, regulated, and clinical global markets. You will serve as the subject matter expert to the executive team and provide guidance in areas related to quality, compliance, regulations, and clinical documentation for global registration. By working closely with the leaders of the company ac...

Responsibilities: Primary Responsibilities: 1. Regulatory Filings and Compliance of regulatory documents: • Coordinating for planning and execution of device regulatory submissions and all other regulatory related activities, globally • Responsible to assist in activities of authoring, review, submission of device related sections of different combination products • Responsible for preparing the response and submission for any agency queries information request on device activities. • Responsible for ISO 13485/ CE certification audit compliance pertaining to regulatory activities and contributes towards post audit management. • Responsible for device related sections in post approval variati...

Job Title: QC Analyst I At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagno...

The Product Owner is responsible for the definition and delivery of a part of a product from a customer and market requirement point of view - regarding content, prioritization, quality and customer excitement for a given cost and time frame. Responsible for a part of the product through the product life cycle from the definition to the phase-out. Provides the associated development teams with priorities and expertise regarding the product and ensures completeness and consistency of the derived requirements within the part of the product. Responsible for definition and delivery of a part of a product from a customer and market requirement point of view, working with one or several developmen...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Quality engineer to support PSUR activities for NV OU Careers that Change Lives As a Quality Engineer you will be a key member of the Medtronic Post Market Quality Engineering team responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety. A Day in the Life Prepare and compile product pos...

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quali...

Vice President - Cyber Security Operations Job Statement: NopalCyber makes cybersecurity manageable, affordable, reliable, and powerful for companies that need to be resilient and compliant. Managed extended detection and response (MXDR), attack surface management (ASM), breach and attack simulation (BAS), and advisory services fortify your cybersecurity across both offense and defense. AI-driven intelligence in our Nopal360° platform, our NopalGo mobile app, and our proprietary Cyber Intelligence Quotient (CIQ) lets anyone quantify, track, and visualize their cybersecurity posture in real-time. Our service packages, which are each tailored to a client’s needs and budget, and external threat...

At Armor, we are committed to making a meaningful difference in securing cyberspace. Our vision is to be the trusted protector and de facto standard that cloud-centric customers entrust with their risk. We strive to continuously evolve to be the best partner of choice, breaking norms and tirelessly innovating to stay ahead of evolving cyber threats and reshaping how we deliver customer outcomes. We are passionate about making a positive impact in the world, and we’re looking for a highly skilled and experienced talent to join our dynamic team. Armor has unique offerings to the market so customers can a) understand their risk b) leverage Armor to co-manage their risk or c) completely outsourc...

Prepare, review, and file global premarket documents, collaborate with teams, develop regulatory strategies, and ensure compliance with India, US FDA, and EU regulations for medical devices or pharmaceuticals.

Job Description Job Overview: The Principal Auditor is primarily responsible for guiding the financial, operational, business process or compliance audit towards successful completion at McDermott across the globe. The Principal Auditor effectively interfaces with various levels of management and develops relationships that further the organizational goals. The Principal Auditor should demonstrate high energy, be flexible and innovative and motivated to work in a fast paced and challenging environment that continues to evolve. The position in an individual contributor and reports to Senior Manager, Audit. The Principal Auditor position does not have formal supervisory responsibility for the ...

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...

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 collab...