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Job ad: Regulatory Affairs & Quality Assurance Manager
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Ossiform ApS, Odense
To continue the regulatory approval processes as well as maintaining and developing the QA processes we are seeking a highly skilled Regulatory Affairs & Quality Assurance Manager.
The RA/QA Manager will lead a team of RA & QA professionals and work closely with internal colleagues as well as CROs and consultants to ensure compliance as we bring innovative products to a world-wide market.
Key Responsibilities
- Lead the Quality Assurance and Regulatory Affairs team.
- Arrange, prepare for, and potentially lead meetings with the FDA, International Agencies, Notified Bodies, etc. to establish agreed upon regulatory requirements for novel medical devices.
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