Partnering with one of our main clients in the Medical Device Industry, currently looking for a Regulatory Affairs Consultant for a 12 1/2 month contract in Switzerland, starting in December.
Regulatory Affairs - Life Cycle management (LCM) RA support:
- Support the LCM Regulatory Affairs group in creation and maintenance of technical documentation
- Supporting compliance to EU MDR and European Council Directive 92/42/EEC or Regulation 2017/745, as applicable,
- US FDA 510(k) submissions and country registrations on a world-wide basis
- MEDDEV guidance documents applicable to Medical Devices products and processes
- ISO 13485 and ISO 9001, QSR
- Creating, reviewing and maintaining regulatory related technical documentation
- Review of submission content as needed; assisting in review of international product technical documents, marketing and labeling materials
If you are interested in this long term opportunity, please apply directly via the link.