Regulatory Affairs Specialist

Regulatory Affairs Specialist / Technical Writer

Hertford, Hertfordshire | Hybrid Working Available
£40,000
37 hours per week over 4.5 days

Regulatory Affairs Specialist / Technical Writer

Are you an experienced Regulatory Affairs or Quality professional looking for a varied role within a growing UK medical device manufacturer?

We are supporting a well established manufacturer of medical devices in Hertfordshire as they look to appoint a Regulatory Affairs Specialist to join their Quality and Regulatory team.

This newly created role offers the opportunity to take ownership of regulatory compliance across a portfolio of Class I and Class IIa devices, while supporting the transition from MDD to MDR.

These are straightforward, well-understood products with no sterile, clean room or patient contact requirement, ideal for someone who enjoys regulatory work without high product complexity.

Responsibilities

• Maintain UK and EU device registrations
• Manage Technical Documentation and Technical Files
• Support new product documentation
• Prepare PMS, PSUR, CEP and CER reports
• Review and update IFUs
• Monitor regulatory changes and ensure compliance
• Support audits and provide regulatory input
• Produce gap analyses and technical justifications
• Provide regulatory information to stakeholders
• Maintain accurate documentation records
• Support the wider Quality team

Requirements

• Experience in Regulatory Affairs, QA or Technical Documentation within medical devices
• Knowledge of ISO13485, UKCA, MDD and MDR
• Experience maintaining Technical Files
• Strong technical writing skills
• Experience within an ISO QMS
• High attention to detail and organisation
• Comfortable working in an SME environment

Desirable Experience

• Internal Auditor training (ISO9001 or ISO13485)
• Engineering or manufacturing background
• Experience with MDR transitions or product registrations

You will join a growing UK manufacturer, working closely with senior leadership and playing a key role in maintaining compliance across an established product range.

Unfortunately, sponsorship is not available for this position, so applicants must already hold full and unrestricted right to work in the UK.