At a Glance
- Tasks: Manage regulatory documentation for medical devices and ensure compliance throughout their lifecycle.
- Company: Growing medical device manufacturer with a supportive SME culture.
- Benefits: 37-hour week, hybrid working, early finishes, and ongoing training.
- Other info: Direct access to senior management and opportunities for career growth.
- Why this job: Join a dynamic team and make a real impact in the medical device industry.
- Qualifications: Experience in regulatory affairs and technical writing within the medical device sector.
The predicted salary is between 40000 - 50000 £ per year.
- Medical Device Regulatory Specialist
- Hertfordshire – 37‑Hour Week, 4½‑Day Week, Hybrid Working Available, Permanent Opportunity
About the Role
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.
- What You Will Be Doing
- 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
What We're Looking For
- Previous Regulatory Affairs experience within the medical device industry
- Strong knowledge of ISO13485, 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
Desirable
- Internal Auditor qualification (ISO9001 or ISO13485)
- Engineering or manufacturing background
- Experience working within an SME environment
Benefits
- 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
- #J-18808-Ljbffr
Contact Details:
Lawrence Dean Recruitment Ltd Recruitment Team
We think you need these skills to ace Medical Device Regulatory Specialist in Hertford
Regulatory Affairs
Technical Writing
ISO 13485
UKCA Compliance
CE MDD Compliance
MDR Regulations
Technical File Preparation
