Governance & Risk Lead at Chain IQ responsible for S2C and P2P service delivery excellence. Collaborating closely with internal teams to manage risks and ensure quality compliance.
About the role
- 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
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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