Staff Regulatory Specialist- Post Market Intelligence
Stryker · Gurugram, India
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Staff Regulatory Specialist responsible for adverse event assessment and regulatory reporting for medical devices across global markets. The role involves evaluating complaints, preparing MDR submissions, supporting post-market surveillance activities, and collaborating with cross-functional teams to ensure timely compliance with applicable regulations.
What they're looking for
- Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, or Regulatory Affairs
- 7-10 years of experience in adverse event reporting within medical device or regulated industries
- Working knowledge of global medical device regulations and post-market surveillance processes
- Experience evaluating complaints and determining regulatory reportability and timelines
- Strong analytical skills with attention to detail and cross-functional collaboration abilities
- Proficiency in Microsoft Office applications, particularly Excel and PowerPoint
- Ability to manage multiple priorities and meet time-sensitive regulatory deadlines independently
What you'll be doing
- Assess adverse events and conduct regulatory reporting activities for medical devices per global requirements
- Review product complaints and post-market data to determine reportability and applicable reporting timelines
- Prepare, submit, and maintain MDRs and regulatory submissions to health authorities
- Collaborate with Quality, Regulatory Affairs, Medical Safety, and Complaint Management teams to ensure accurate, timely submissions
- Support post-market surveillance by analyzing complaint data to identify emerging safety signals and trends
Privacy & handoff
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