Specialist Vigilanz & Post-Market Surveillance

Job Summary

The role involves monitoring medical device safety after market entry, assessing incidents, and handling regulatory reporting. The specialist evaluates events, decides on reporting requirements in line with international regulations, and prepares post-market surveillance documentation. Responsibilities include coordinating risk analyses, determining necessity for recalls or corrective actions, and serving as the primary contact for authority inquiries. The position also updates SOPs based on MDR, MDCG guidelines, and keeps the team informed of any changes. Candidates should have an engineering or natural science degree, strong analytical skills, and proficiency in German (C1) and English (B2). Experience in quality management (ISO 13485) and familiarity with MDR, ISO 14971, and other relevant regulatory frameworks are preferred. The job offers a stable, purpose‑driven role with competitive pay, structured onboarding, and a hybrid work setup at the company’s Munich Innovation Campus.

Key Responsibilities

• The role involves monitoring medical device safety after market entry, assessing incidents, and handling regulatory reporting. The specialist evaluates events, decides on reporting requirements in line with international regulations, and prepares post-market surveillance documentation. Responsibilities include coordinating risk analyses, determining necessity for recalls or corrective actions, and serving as the primary contact for authority inquiries. The position also updates SOPs based on MDR, MDCG guidelines, and keeps the team informed of any changes. Candidates should have an engineering or natural science degree, strong analytical skills, and proficiency in German (C1) and English (B2). Experience in quality management (ISO 13485) and familiarity with MDR, ISO 14971, and other relevant regulatory frameworks are preferred. The job offers a stable, purpose‑driven role with competitive pay, structured onboarding, and a hybrid work setup at the company’s Munich Innovation Campus.

About the Role

This role is ideal for someone who enjoys combining strategy, content, data and execution. You will work with cross-functional teams and contribute directly to the company’s digital growth in Kolkata and surrounding areas.

Job Requirements

• Regulatory Affairs
• Risk Management

Required Skills