Job ad: Regulatory Affairs & Quality Assurance Manager

Ossiform ApS Regulatory Affairs & Quality Assurance Manager

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.