Post Market Surveillance Manager monitoring market data and ensuring compliance for medical products. Collaborating with risk management and developing post-market surveillance systems.
Responsibilities
Analysis of market data: Monitor and evaluate market data as part of post-market surveillance for medical devices across the entire product lifecycle
Post-market surveillance plans: Create, maintain and update post-market surveillance plans and related reports (e.g., PSUR/PMSR) in accordance with regulatory requirements
Evaluation of field feedback: Analyze complaints, vigilance data, market observations and clinical follow-up data
Risk assessment: Perform trend analyses and statistical evaluations and identify potential safety or performance issues
Internal collaboration: Work closely with risk management and other departments to ensure that all field-derived findings are processed appropriately
Audits: Support audits and regulatory inspections in the area of market surveillance and ensure compliance with internal processes
Contributing to the post-market surveillance system: Actively participate in the further development of the global post-market surveillance system and its underlying processes
Requirements
Several years of professional experience in post-market surveillance, vigilance, quality management or comparable roles
A degree in a scientific, technical or business discipline is desirable
Initial experience with regulatory requirements and in preparing and maintaining regulatory documentation relevant to medical devices
Analytical mindset, structured and independent working style
Very good German and English language skills
Benefits
Flexible working hours & mobile working: In many areas, working hours and location can be arranged as needed
30 days of annual leave and various additional payments
Training opportunities: Open in-house seminar program, extensive e-learning offering, professional training and more
Corporate benefits programs and bike leasing
Contribution to private retirement plans and company health management
Various childcare options – available at the headquarters in Tuttlingen
Health, sports, cultural and leisure offerings – these vary by location
Job title
Post Market Surveillance Manager – fixed-term 24 months
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