Our client, a medical device development company, is currently looking for a Regulatory Affairs Specialist to join their team in the South East of England.
This is an exciting opportunity that will allow you to work alongside newly developed medical devices. These devices are at pre-market phase; in Europe they are undergoing testing in clinical studies ready for the CE mark and launch, and in the US they are ready for IDE studies.
Further responsibilities of these Regulatory Affairs Specialist role include:
- Be required to make use of US and EU regulatory knowledge.
- Have experience with class IIb and III medical devices, orthopaedics/spinal implant knowledge would be advantageous.
- Be competent with the submission of technical documents.
- Be required to produce regulatory documents to the highest standard.
The successful candidate will have demonstrable competence in the following:
- Ability to work to tight deadlines
- Able to produce documentation to a high standard as required for regulatory submissions / correspondence.
- Self-directed and motivated
- Working understanding of US and EU regulatory requirements
- Understanding of knowledge of Vigilance and PMS requirements
- Sound knowledge of label and labeling requirements
If you would like to know more about this vacancy, or would like to discuss other similar roles please call Meera on 01438 743047. Alternatively, please send your CV for consideration to: firstname.lastname@example.org. To apply for this role, please click here.
About CK Regulatory
CK Regulatory is a specialist Recruitment company offering job opportunities to Regulatory Affairs professionals seeking work in Pharma, Biotechnology, Medical Devices and Regulatory Consultancies. As part of CK Clinical we have an established and enviable track record of providing a high quality recruitment service to Pharmaceutical professionals.