Job Description

Role Overview

We are seeking an experienced Product Risk Management Owner to lead and maintain the risk management process for medical devices throughout their lifecycle.

This role ensures compliance with ISO 14971, EU MDR, FDA 21 CFR 820 , and other applicable global standards.

The selected professional will collaborate closely with R&D, Clinical, Regulatory, and Quality teams to identify, assess, document, and communicate product risks — ensuring patient safety, design compliance, and regulatory readiness.

Key Responsibilities

Risk File & Documentation Management

• Develop, maintain, and own the Risk Management File (RMF) and associated Design History File (DHF) documents.
• Ensure all risk-related documentation (RMP, RMR, FMEA, HA) is accurate, compliant, and traceable .
• Maintain traceability matrices between risk controls, design inputs, and verification outputs.

Risk Assessment & Review

• Conduct regular risk reviews to evaluate product safety and performance.
• Manage and implement RMF updates based on design changes, CAPA, complaints, or post-market data .
• Identify and assess hazards, hazardous situations, and potential harms for new and legacy products.
• Evaluate the emergence of new risks from field data and regulatory updates.

Cross-Functional Collaboration

• Lead and coordinate cross-functional risk management reviews with R&D, Clinical, Regulatory, and Quality.
• Partner with Clinical and Medical Affairs to evaluate and approve new hazard assessments.
• Ensure risk content and deliverables are technically accurate and reviewed by qualified members.

System Engineering Support

• Provide guidance to design teams on risk mitigation and verification planning .
• Maintain traceability across design input → risk control → verification output .
• Support system-level V&V plans, FMEAs, and CAPA activities .
• Mentor engineering team members on risk management best practices and design reliability.

Communication & Risk Strategy

• Develop mechanisms to document and communicate product risk strategy across departments.
• Present risk assessments and mitigation updates to internal and external stakeholders .
• Collaborate with Product Safety and Regulatory teams to ensure alignment on risk strategy and documentation.

Required Qualifications

• Bachelor’s or Master’s Degree in Biomedical, Mechanical, Electrical, or Quality Systems Engineering.
• 8+ years of experience in medical device risk management, design quality, or product safety .
• Hands-on experience with ISO 14971, EU MDR, FDA 21 CFR 820 , and Design Control processes.
• Proven background in FMEA, Hazard Analysis, RMP/RMR development, and RMF maintenance .
• Experience supporting Class II / III medical device products (software or embedded systems preferred).
• Strong collaboration with cross-functional teams (R&D, Regulatory, Clinical, Quality) .
• Familiar with tools like TrackWise, MasterControl, Agile PLM, SAP, DOORS, Minitab .

Preferred

• ASQ certifications ( CQE, CQA, CRE, or CSSBB ).
• Knowledge of software risk management (IEC 62304, IEC 60601).
• Exposure to post-market surveillance and CAPA management .

Soft Skills

• Excellent written and verbal communication.
• Strong analytical and documentation skills.
• Able to lead discussions with technical and regulatory teams.
• Proactive, detail-oriented, and organized under tight deadlines.

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