PANDA INTERNATIONAL is a specialist recruitment agency dedicated to placing high-level candidates in freelance and temporary roles within the Pharmaceutical, Medical Device, Biotech and Food sectors across Europe. By working closely with candidates and companies in meeting challenging business demands, the Panda team has developed an extensive client base consisting of the world’s leading Life Sciences organizations.
For a Medical Device client in the Noord-Holland, The Netherlands, we are currently looking for a Regulatory Affairs & Quality Manager.
Responsible for an efficient and up to date QMS
Member of the Management Team and support growth and development of the company
RA/QA strategy, guidelines, direction, documentation, implementation, approving products
Collect data and prepare submissions to regulatory agencies
Responsible for Global RA/QA and inform the company about the newest international regulations
Lead and support teams regard to regulatory requirements
Release of quality documents conformance with the Quality QMS
RA for 510k, CE files, commercial products
Spending within the limit of the global policy
Managing a Quality Engineer.
Master or Bachelor degree
At least 5 years experience in a regulatory related field
Management skills, can work in a team and independently.
Good networker and can level with people from several divisions
Work precisely, accurate, follow plan and coordinated
Can work under pressure with deadlines
Open minded, very communicative
Fluent in English and Dutch is preferable. German would be nice.
At least 1 year
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