Regulatory Affairs Specialist Quality Engineer

Regulatory Affairs Specialist / Technical Writer

Hertfordshire
Annual Salary £40,000
37-Hour Week | 4½ Day Week | Hybrid Working Available
Permanent Opportunity

Are you an experienced Regulatory Affairs Specialist with a background in medical devices? Do you enjoy technical writing, regulatory compliance, and ensuring products meet the highest quality standards?

An exciting opportunity has arisen for a Regulatory Affairs Specialist / Technical Writer to join a growing UK manufacturer of medical devices. This newly created role offers the opportunity to become a key member of the Quality & Regulatory Affairs team, helping to maintain regulatory compliance across an established product range whilst supporting exciting new product developments.

Working closely with the Quality Manager, Directors, and Engineering team, you'll play a pivotal role in maintaining technical documentation, supporting regulatory submissions, and ensuring compliance with UK and European medical device regulations.

As Regulatory Affairs Specialist / Technical Writer, you will take ownership of regulatory documentation for Class I and Class IIa 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 Market 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

To be successful in this role, you will ideally have:

• 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

• Salary circa £40,000
• 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

Desirable:

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

Thank you for your application.