Work Flexibility: Hybrid

What you will do-
- Perform adverse event assessment and regulatory reporting activities for medical devices in accordance with applicable global regulatory requirements.
- Review and evaluate product complaints and post-market information to determine reportability, regulatory timelines, and applicable reporting requirements.
- Prepare, submit, and maintain adverse event reports / Medical Device Reports (MDRs) and other regulatory submissions to applicable health authorities.
- Support post-market surveillance activities by analyzing complaint and adverse event data to identify emerging trends, potential safety signals, and reportable events.
- Collaborate with Quality, Regulatory Affairs, Medical Safety, Engineering, Clinical, and Complaint Management teams to obtain information required for timely and accurate regulatory reporting and ensure regulatory submissions are complete, accurate, consistent, and submitted within defined timelines.
- Support regulatory reporting activities across multiple global markets, as applicable,



including US and Europe and maintain accurate documentation and records related to adverse event assessments, regulatory submissions, follow-ups, and correspondence with health authorities.
- Perform follow-up activities for adverse events, including gathering missing information and updating regulatory reports when required.
- Support regulatory and internal audits by providing appropriate documentation, records, and evidence related to post-market reporting activities.
- Identify opportunities to standardize, simplify, and automate PMI/AER processes while maintaining compliance with applicable regulations and procedures.
- Participate in process improvement, risk management, and continuous improvement initiatives within the Post Market Intelligence organization.
- Stay current with changes in global medical device regulations, reporting requirements, guidance documents, and internal procedures relevant to adverse

📌 Staff Regulatory Specialist- Post Market Intelligence (Gurugram)
🏢 Stryker
📍 Gurugram