Description
We are looking for a
Compliance Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Bavaria
Branch: Pharmazeutische Industrie
Your tasks:
- Ensure implementation and maintenance of all required medical device certifications and management reviews for all products and combination products manufactured across the BTDM network in accordance with cGMP, legal & regulatory requirements and the Corporate Quality Manual
- Accountable for the escalation of quality & compliance issues associated with medical devices to management in accordance with global requirements
- Drive the implementation of remediation actions in a timely and robust manner
- Communication and interface with external contacts (industry and health authorities), where appropriate
- Participate in external working groups or standards setting organizations to influence the global regulatory and/or technical requirements impacting medical device, biologics and combination products
Your qualifications
- Degree in engineering/chemistry, pharmacy, microbiology or biotechnology or another related science
- Fluency in English (speaking/writing)
- German and/or French skills desirable
- Good compliance knowledge of cGMP
- Working knowledge of medical device and combination product regulations, standards and guidelines
Skills:
- Quality management employee
- Compliance manager
Keywords: Mitarbeiter Qualitätsmanagement