Staff Regulatory Specialist – Post Market Intelligence

Role Overview

The Staff Regulatory Specialist – Post Market Intelligence will perform adverse event assessment and regulatory reporting activities for medical devices in accordance with applicable global regulatory requirements. The role involves reviewing and evaluating product complaints and post-market information to determine reportability, regulatory timelines, and applicable reporting requirements. The specialist will prepare, submit, and maintain adverse event reports / Medical Device Reports (MDRs) and other regulatory submissions to applicable health authorities.

What You Will Do

The Staff Regulatory Specialist – Post Market Intelligence will perform follow-up activities for adverse events, support regulatory and internal audits, and identify opportunities to standardize, simplify, and automate PMI/AER processes while maintaining compliance with applicable regulations and procedures.

Why It Might Be a Fit

The ideal candidate will have a strong analytical and problem-solving skills with a high level of attention to detail and accuracy, and the ability to interpret and apply regulations, regulatory guidance, and internal procedures to individual cases.

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, Regulatory Affairs, or a related field
• 3 years of experience in Adverse event reporting within the medical device, healthcare, pharmaceutical, or life sciences industry
• Relevant experience in medical device, pharmaceutical, healthcare, or other regulated industry, preferably in Post Market Surveillance, Regulatory Affairs, Complaint Management, or Adverse Event Reporting
• Working knowledge of global medical device regulatory requirements and adverse event reporting processes
• Understanding of post-market surveillance, vigilance, complaint handling, and medical device safety concepts
• Experience in evaluating complaints and determining regulatory reportability and applicable reporting timelines
• Ability to interpret and apply regulations, regulatory guidance, and internal procedures to individual cases
• Ability to work independently, make sound decisions within defined procedures, and escalate complex or potentially high-risk cases appropriately
• Strong analytical and problem-solving skills with a high level of attention to detail and accuracy
• Written and verbal communication skills, with the ability to collaborate effectively with cross-functional and global teams
• Proficiency in Microsoft Office applications, particularly Excel and PowerPoint

Tagged as: Excel