Safety and Reporting Senior Specialist – Post Market Quality As a Safety and Reporting Senior Specialist of Post Market Quality, you will be a key player within our Quality and Regulatory organization. Working with a high degree of autonomy and minimal supervision, you will ensure our products maintain the highest standards of safety and compliance after they reach the market. You will dive into complex cases, collaborate globally, and contribute to continuous improvement in a dynamic, patient‑centric environment.
Responsibilities Case & Report Management: Take accountability for the timely and compliant handling of safety, vigilance, and Post‑Market Surveillance (PMS) cases/reports, strictly adhering to ISO Quality System requirements and country‑specific regulations.
Regulatory & Affiliate Collaboration: Interface directly with Regulatory Authorities (e.G., FDA, Notified Bodies) and Affiliate Organizations. Coordinate, prepare, and deliver precise responses by collaborating...