Medical Device Regulatory Specialist

Medical Device Regulatory Specialist

Hertfordshire – 37‑Hour Week, 4½‑Day Week, Hybrid Working Available, Permanent Opportunity

As Regulatory Affairs Specialist / Technical Writer, you will take ownership of regulatory documentation for ClassI and ClassIIa medical devices, ensuring products remain compliant throughout their lifecycle. This is a varied role combining regulatory affairs, technical writing, quality support, and continuous improvement, making it ideal for someone who enjoys working across multiple disciplines within a collaborative SME environment.

• Maintain medical device registrations across the UK and EU
• Review, maintain, and update Technical Files for existing and new medical devices
• Prepare and maintain technical documentation to support regulatory compliance
• Review and update Instructions for Use (IFUs), technical reports, and regulatory documentation
• Prepare validation documents, gap analyses, technical justifications, and briefing papers
• Support UKCA, CE, MDD, and MDR compliance activities
• Monitor changes to regulatory legislation and implement updates where required
• Support external audits and provide regulatory input
• Produce Post Marketing Surveillance (PMS), PSUR, CEP, and CER documentation
• Liaise with customers and regulatory bodies regarding product compliance
• Maintain organised regulatory and quality records
• Deputise for the Quality Manager or Quality Engineer when required

• Previous Regulatory Affairs experience within the medical device industry
• Strong knowledge of ISO
  13485, UKCA, CE MDD, and MDR regulations
• Experience preparing and maintaining Technical Files
• Technical writing experience within a regulated environment
• Experience working within an ISO‑regulated Quality Management System
• Excellent written communication and document control skills
• Strong analytical and problem‑solving abilities
• High attention to detail and excellent organisational skills
• Ability to work independently and manage multiple priorities

• Internal Auditor qualification (ISO
  9001 or ISO
  13485)
• Engineering or manufacturing background
• Experience working within an SME environment

• 37‑hour working week over 4½ days
• Hybrid working available
• Early finish on Fridays
• Opportunity to join a growing medical device manufacturer
• Supportive SME environment with direct access to senior management
• Ongoing training and professional development
• Opportunity to influence regulatory and quality improvements