Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist will join the Regulatory Affairs team at a leading developer of consumer diagnostic products, based at the Innovation Centre in Bedford. Working on a 12‑month fixed‑term contract, the role supports the international distribution and product change implementation for home pregnancy and fertility monitoring tests, with a hybrid working model.

Key responsibilities

• Provide technical support to ensure regulatory compliance for all marketed products across international markets.
• Validate product claims on a market‑specific basis and maintain up‑to‑date documentation.
• Conduct regulatory reviews of complaints, assess reportability and liaise with relevant authorities.
• Assist with CE marking activities and coordinate changes with Notified Bodies.
• Support the preparation and submission of regulatory dossiers for in‑vitro diagnostic and medical devices.

Required profile

• Minimum BSc degree or equivalent experience in life sciences (e.g., biology, biochemistry, pharmacology).
• Strong knowledge of CE marking requirements for in‑vitro diagnostic medical devices and broader medical device regulations.
• Familiarity with international regulatory frameworks and experience working with Notified Bodies or regulatory agencies is desirable.
• Excellent written and oral communication skills with the ability to convey complex technical information.

Required skills

• CE marking
• In‑vitro diagnostic device regulations
• Medical device regulations
• Notified Body liaison

What we offer

• Hybrid working arrangement.
• Annual discretionary bonus.
• 25 days paid annual leave plus bank holidays.
• Company pension with competitive employer contribution.
• Private medical insurance and additional cash plan.
• Enhanced maternity and paternity pay.
• Health and wellbeing programme and life assurance.
• Free electrical car charging points and parkland setting with good transport links.