Compliance Manager (m/f)

REFERENZNUMMER:

311632/3

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Compliance manager, Quality management employee