Hello,

My name is Nagendra P. from HRS Navigation. We are currently seeking a skilled Risk Management Specialist to join our team. If you are interested or open to a new career chance, please share your updated resume with me at [email protected] or +91-XXXXXXXXXX via WhatsApp.

Risk Management Specialist – Medical Devices (3–5 years) | Surgical Navigation Systems

Role summary

Own and maintain risk management documentation for surgical navigation systems, including active medical devices, software-driven systems, instruments, accessories, and related non-active devices, in compliance with ISO 14971, EU MDR, US FDA expectations, ISO 13485, and internal QMS requirements.

Key responsibilities

- Prepare and maintain risk management plans, hazard analysis, FMEA, risk evaluation, risk control, risk-benefit analysis, and risk management reports.
- Develop and update Design FMEA, Software FMEA, Use-Related Risk Analysis / URRA, and Process FMEA, as applicable.
- Ensure risk controls are linked with design requirements, verification evidence, validation evidence, usability inputs, labeling/IFU, clinical evaluation, and post-market data.
- Assess residual risks and support overall benefit-risk justification.
- Perform risk impact assessments for design changes, software changes, manufacturing changes, supplier changes, labeling changes, and regulatory changes.
- Ensure risk files are updated based on change control, CAPA, complaints, PMS/PMCF, clinical evaluation, and vigilance inputs.
- Support GSPR documentation by ensuring proper linkage between risks, applicable requirements, controls, and objective evidence.




- Provide risk-based inputs to R&D;, Software, V&V;, QA/RA, Clinical, Manufacturing, and Service teams.
- Support V&V; and usability teams with risk-based inputs for test planning, acceptance criteria, validation approach, and evidence review.
- Support audit readiness, regulatory submissions, and Notified Body / regulatory authority queries from a risk management perspective.
- Support improvement of risk management SOPs, templates, checklists, and trackers.

Must-have qualifications

- 3–5 years of experience in medical device risk management, design assurance, QA, RA, or product development.
- Hands-on experience with ISO 14971-based risk management documentation.
- Good understanding of hazard analysis, FMEA, risk controls, residual risk evaluation, and risk management reports.
- Experience in risk impact assessment for product, software, process, supplier, or labeling changes.
- Strong documentation, traceability, technical writing, and cross-functional coordination skills.

Nice to have

- Exposure to active medical devices, medical software, surgical navigation systems, imaging systems, robotic systems, or electromechanical medical devices.
- Working knowledge of EU MDR GSPR, ISO 13485, IEC 62304, IEC 62366-1, IEC 60601-1/-1-2, ISO 10993, and US FDA expectations.
- Exposure to V&V; documentation, usability engineering, clinical evaluation, PMS/PMCF, CAPA, complaints, audits, and regulatory submissions.
- Training or certification in ISO 14971, ISO 13485, EU MDR, or medical device QMS will be preferred.

Pay: ₹9,750.51 - ₹99,578.87 per month

Work Location: In person

📌 Risk Management Specialist (India)
🏢 HRS Navigation
📍 India