Regulatory and Quality Manager - Oxford
Mary Bolt is recruiting for a Regulatory and Quality Manager to join a company in the Medical Device industry at their site based in Oxford on a permanent basis.
Our client is an extremely interesting start-up developing devices to prevent brain haemorrhage. This is an exciting time to join the company as they head towards the Clinical phases of development in a small focus team with technology that has won a number of industry awards.
The role is based at our client's site in Oxford, a city famous for it's history and university that offers a combination of both ancient and modern and a wide variety of places to visit.
The main purpose of the role will be to:
- Lead the drive to obtain regulatory approvals including CE marking, FDA approval and others as the company commercialises.
- Develop, maintain and manage the Quality Management Systems.
- Prepare for the transition to EU MDR including the up-rating of device classifications and for transition to MDSAP.
- Compile and maintain technical files, company registration and regulatory submissions and work with notified bodies for CE mark approval.
- Write and submit 510(k) pre-market notifications to FDA.
- Work closely with and manage multiple 3rd party suppliers
To succeed in this role, you will come from a background in:
- Educated to degree level or above in life science or a related field with extensive experience within Regulatory Affairs and Quality in the Medical Device industry.
- Proven success with Class III medical devices (ideally impantable vascular) gaining CE mark and FDA and other market approvals including writing and submitting 510(k) pre-market notifications to FDA.
- Detailed Knowledge of ISO9001, ISO13485:2016 Quality Management Systems Requirements, ISO 14971 Risk Management requirements, IEC 62304 and IEC 62366 requirements, CMDCAS and FDA 21 CFR Part 820 QSR as well as sound knowledge of the Medical Device Directive and how it is evolving.
- A strong and clear communicator and presenter with excellent interpersonal skills who is composed under pressure with a can-do attitude as well as being a leader and self-starter.
For more information or to apply for this position, please contact Mary Bolt on 01438 768717 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 43870 in all correspondence.