Job Title: Risk Management SME – Medical Devices
Location: Pune
Employment Type: Full-Time
Experience: 10+ Years
Industry: Medical Devices
Job Summary:
We are seeking a highly experienced Risk Management Subject Matter Expert (SME) with a strong background in medical device regulatory and quality systems. The ideal candidate will have 10+ years of experience working with cross-functional teams including R&D, Regulatory Affairs, and Design Quality to ensure product compliance throughout the lifecycle. This role requires deep knowledge of risk management, global regulatory requirements (EU MDR, US FDA 510(k)), and relevant medical device standards.
Key Responsibilities:
• Lead and execute risk management activities throughout the product lifecycle.
• Review and simplify Risk Management Files (RMF), Risk Mitigation Measures (RMM), BRDs, DHFs, traceability matrices, design requirements, and IFUs.
• Ensure compliance with global medical device regulations and standards (ISO 14971, ISO 13485, IEC 60601-1, IEC 62366-1, ISO 10993-1, MEDDEV 2.7/4).
• Collaborate with R&D and Quality teams to validate design inputs (Usability, Safety, Reliability, etc.).
• Oversee and contribute to Verification & Validation (V&V) activities.
• Manage quality plans across all stages of the product lifecycle and ensure execution oversight.
• Conduct technical assessments and post-market analysis on product performance.
• Provide analytics and statistical reporting for post-market surveillance.
• Act as the primary quality representative in project teams ensuring design compliance at every milestone.
Requirements:
• Degree in Mechanical/Electrical Engineering, Applied Sciences, or related field.
• 10+ years of experience in medical device industry focusing on risk management and regulatory compliance.
• Expertise in quality management systems (QMS) like ISO 13485, MDSAP, and EU MDR.
• Hands-on experience with quality and product development systems.
• Strong communication and cross-functional collaboration skills.
• Proven ability to drive quality excellence and compliance.
<p>Job Title: Risk Management SME – Medical Devices<br> Location: Pune <br> Employment Type: Full-Time<br> Experience: 10+ Years<br> Industry: Medical Devices</p><br> <p>Job Summary: <br> We are seeking a highly experienced Risk Management Subject Matter Expert (SME) with a strong background in medical device regulatory and quality systems. The ideal candidate will have 10+ years of experience working with cross-functional teams including R&D, Regulatory Affairs, and Design Quality to ensure product compliance throughout the lifecycle. This role requires deep knowledge of risk management, global regulatory requirements (EU MDR, US FDA 510(k)), and relevant medical device standards. <br></p> <p>Key Responsibilities: <br> • Lead and execute risk management activities throughout the product lifecycle. <br> • Review and simplify Risk Management Files (RMF), Risk Mitigation Measures (RMM), BRDs, DHFs, traceability matrices, design requirements, and IFUs. <br> • Ensure compliance with global medical device regulations and standards (ISO 14971, ISO 13485, IEC 60601-1, IEC 62366-1, ISO 10993-1, MEDDEV 2.7/4). <br> • Collaborate with R&D and Quality teams to validate design inputs (Usability, Safety, Reliability, etc.). <br> • Oversee and contribute to Verification & Validation (V&V) activities. <br> • Manage quality plans across all stages of the product lifecycle and ensure execution oversight. <br> • Conduct technical assessments and post-market analysis on product performance. <br> • Provide analytics and statistical reporting for post-market surveillance. <br> • Act as the primary quality representative in project teams ensuring design compliance at every milestone. <br></p> <p>Requirements: <br> • Degree in Mechanical/Electrical Engineering, Applied Sciences, or related field. <br> • 10+ years of experience in medical device industry focusing on risk management and regulatory compliance. <br> • Expertise in quality management systems (QMS) like ISO 13485, MDSAP, and EU MDR. <br> • Hands-on experience with quality and product development systems. <br> • Strong communication and cross-functional collaboration skills. <br> • Proven ability to drive quality excellence and compliance. <br></p>