Regulatory Compliance Expertise
This role demands a high level of technical expertise, leadership skills, and collaboration across functions to strengthen post-market surveillance (PMS) effectiveness.
Key Responsibilities:
1. Apply in-depth knowledge of vigilance processes, complaint handling, and reportability to drive effective PMS activities.
2. Analyze performance data from TrackWise or other complaint-handling systems to inform business decisions.
3. Create and maintain compliant Post Market Surveillance documents according to regulatory requirements.
4. Develop PMS plans, reports, and periodic safety update reports that meet regulatory standards.
5. Collaborate with cross-functional teams, including clinical, marketing, medical affairs, regulatory affairs, and R&D.
The ideal candidate will possess strong analytical skills, experience in PMS data trending, and statistical analysis. They must also demonstrate advanced organizational and time management skills, as well as in-depth knowledge of PMS regulations.