Job Description
Posted Friday 24 April 2026 at 00:00
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
What's in it for you:
- A competitive salary and a discretionary annual bonus
- 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.
Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
#J-18808-Ljbffr”, “datePosted”: “2026-05-02”, “hiringOrganization”: { “@type”: “Organization”, “name”: “Corin Group”, “sameAs”: “https://uk.whatjobs.com/pub_api__cpl__420925883__4861?utm_campaign=publisher&utm_medium=api&utm_source=4861” }, “jobLocation”: { “@type”: “Place”, “address”: { “@type”: “PostalAddress”, “addressLocality”: “” } } }Job Description
Posted Friday 24 April 2026 at 00:00
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
What’s in it for you:
- A competitive salary and a discretionary annual bonus
- 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.
Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
#J-18808-Ljbffr…