We’re recruiting on behalf of a leading organisation in the medical device and diagnostics sector, recognised for driving innovation in diagnostic accuracy and patient care worldwide. As the business continues to grow, they are looking for an experienced Regulatory Affairs Specialist to join them on a 9-month fixed-term contract. There’s a strong possibility this role could become permanent for the right candidate, depending on performance and business needs.
The role:
Reporting to the Regulatory Affairs Manager, you’ll support global regulatory submissions and compliance activities across a diverse portfolio of medical devices and in vitro diagnostics. You’ll work closely 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 regulatory changes and assess their impact on product compliance
- Support audits, inspections and regulatory communications (e.g. Notified Bodies, FDA)
- Provide regulatory input across design control, risk management and post-market surveillance (PMS/PMCF)
- Ensure compliance of labelling, instructions for use and marketing materials
- Contribute to regulatory strategies for new product launches and market expansion
The ideal candidate:
- Degree in Life Sciences, Pharmacy or a related discipline
- Strong experience in regulatory affairs within the medical device or IVD sector
- Solid understanding of EU MDR, EU IVDR, FDA 21 CFR Part 820 and ISO 13485
- Proven experience compiling and maintaining technical documentation for CE marking and FDA submissions
- Familiarity with UDI, MDSAP and international regulatory pathways
- Clear communicator with excellent stakeholder engagement skills
- Confident working independently in a fast-paced, collaborative environment
Desirable:
- 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 supporting notified body interactions or regulatory authority inspections
