Regulatory Affairs Specialist
We are looking for an experienced Regulatory Affairs Specialist to support global medical device registrations and regulatory operations. You will play a key role in pre- and post-market activities, working on implantable devices and innovative technologies.
What you'll do :
- Supporting global registrations (CE marking, FDA 510(k))
- Support correspondence with Regulatory Authorities as required (i.e., prepare additional information or responses as required by regulatory agencies, FDA or NB deficiency responses etc.).
- Managing regulatory operations such as change controls, IFUs, EUDAMED and MHRA
- Review protocols & reports and other documentation used to support medical device files.
- Effectively communicate and collaborate with other personnel within the local and global organization.
- Supporting audits and driving continuous improvement initiative
About you:
- Degree in Life Sciences, Medical or Engineering
- 4+ years’ experience in medical device Regulatory Affairs
- Strong knowledge of global regulations and ISO 13485
- Experience liaising with regulatory authorities (BSI, FDA etc)
- Familiarity in dealing with and interpreting technical and legislative documentation
- Detail oriented and excellent written and verbal communication skills
- Excellent communication skills; orthopaedics experience desirable
What's in it for you:
- A competitive salary and a discretionary annual bonus
- 25 days holiday plus bank holidays
- Excellent pension – starts at 6%, going up to 9.7% after 18 months.
- Life assurance – Six times your basic salary
- Private medical insurance with BUPA for you and your family
- Free annual eye tests and flu vaccinations
- Employee referral program where you can earn up to £1,000 for each successful hire you recommend
Apply now to join a collaborative team working on meaningful, life-changing medical devices.