We are currently recruiting on behalf of a leading organisation in the medical device and diagnostics sector, renowned for their innovation in improving diagnostic accuracy and patient care globally. As part of their continued growth, they are seeking an experienced Regulatory Affairs Specialist for a 9-month fixed-term contract—with a good likelihood of transitioning into a permanent role for the right candidate based on performance and business needs.
The Role
You will be responsible for supporting global regulatory submissions and compliance activities across the company’s portfolio of medical devices and in vitro diagnostics. Reporting into the Regulatory Affairs Manager, you’ll collaborate with cross-functional teams to ensure alignment with EU MDR, IVDR, FDA, and ISO 13485 standards.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for global product registrations, renewals, and technical updates
• Maintain and update Technical Files, Design Dossiers, and Device Master Records
• Monitor global regulatory changes and assess implications for product compliance
• Support audits, inspections, and agency communications (e.g., Notified Bodies, FDA)
• Provide regulatory input across design control, risk management, and post-market surveillance (PMS/PMCF)
• Ensure regulatory compliance of labelling, instructions for use, and marketing materials
• Contribute to regulatory strategies for new product launches and market expansions

Ideal Candidate

• Degree in Life Sciences, Pharmacy, or related discipline
• Solid experience in Regulatory Affairs within the medical device or IVD industry
• In-depth understanding of EU MDR, EU IVDR, FDA 21 CFR Part 820, and ISO 13485
• Experience compiling and maintaining technical documentation for CE marking and FDA submissions
• Familiarity with UDI, MDSAP, and international regulatory pathways
• Strong communication and stakeholder engagement skills
• Able to hit the ground running and thrive in a fast-paced, collaborative setting
• This can be a remote or hybrid role but there will be a need to visit the office on at least a quarterly basis and travelling expenses will be paid.

Nice to Have

• RAPS or TOPRA certification
• Knowledge of emerging market regulations (e.g., Health Canada, TGA, ANVISA)
• Familiarity with standards such as IEC 60601, IEC 62304, ISO 10993, or CLSI guidelines
• Experience working with notified bodies or regulatory authorities during inspections/audits

Job Types: Full-time, Fixed term contract
Contract length: 9 months
Pay: £55,000.00-£60,000.00 per year

Schedule:

• Monday to Friday

Work Location: Remote
Reference ID: 397

• Prepare, review, and submit regulatory documentation for global product registrations, renewals, and technical updates
• Maintain and update Technical Files, Design Dossiers, and Device Master Records
• Monitor global regulatory changes and assess implications for product compliance
• Support audits, inspections, and agency communications (e.g., Notified Bodies, FDA)
• Provide regulatory input across design control, risk management, and post-market surveillance (PMS/PMCF)
• Ensure regulatory compliance of labelling, instructions for use, and marketing materials
• Contribute to regulatory strategies for new product launches and market expansion