Regulatory Affairs Specialist (IVD / Medical Devices)
Location: UK-based (Remote or Hybrid)
Contract: 12 months
Hours: 37.5 per week, Monday–Friday (flexible)
Start date: ASAP
Salary: £60 per hour
Are you an experienced Regulatory Affairs professional with deep expertise in IVD or Medical Device regulations across EMEA? This is an exciting opportunity to take a leading role in supporting regional regulatory strategies, ensuring compliance, and enabling market growth for innovative life science products.
About the Role
As a Regulatory Affairs Specialist, you will lead and manage product and establishment registrations across EMEA, supporting both new market access and ongoing compliance activities. You will collaborate cross‑functionally in a highly international environment, guiding teams and stakeholders while maintaining strong relationships with regulatory authorities and distribution partners.
This role offers the flexibility of remote or hybrid working within the UK, with occasional travel required for escalations or key business needs.
Key Responsibilities
* Lead national product and establishment registrations across EMEA regions.
* Develop and execute registration strategies aligned with commercial and global regulatory objectives.
* Maintain strong professional relationships with regulatory bodies and distributors.
* Perform registrations using relevant national databases and track progress to ensure timely completion.
* Keep regulatory databases accurate, complete, and up to date.
* Organise and maintain activity trackers for product and site registration statuses and associated documentation.
* Review and prepare change control regulatory assessments.
* Manage re-registrations and registration updates as required.
* Monitor evolving EMEA regulatory requirements and provide assessments and guidance.
* Support vigilance activities in collaboration with Post‑Market teams.
* Provide oversight for direct and distributor-led submissions to Competent Authorities.
* Improve internal request management processes and deliver training to relevant stakeholders.
* Conduct regulatory training and share updates through internal intelligence networks.
Minimum Qualifications
* 8–10 years’ Regulatory Affairs experience in IVD or Medical Devices within the EMEA region.
* Strong knowledge of ISO 13485 and European IVD/MD regulatory frameworks.
* Proven experience with national compliance and product registrations across Europe, the Middle East, and Africa.
* Experience serving as an RA representative on cross-functional projects.
* Strong communication experience with regulatory authorities and internal/external partners.
* Understanding of technical and scientific principles related to IVD reagent chemistry, lab automation, and software components.
* Ability to translate regulatory requirements into clear guidance for technical teams.
Skills & Attributes
* High energy, positive mindset, and strong resilience under pressure.
* Excellent verbal and written communication skills across international teams.
* Strong leadership capability and hands-on, action-oriented approach.
* Continuous improvement mindset with a balance of quality and efficiency.
* Ability to work autonomously within a matrix organisation.
* Strong problem-solving skills based on regulatory and industry expertise.
* Comfortable with ambiguity, change, and tight timelines.
* Proficient in PC-based systems and digital communication tools.
* Willingness to travel (10–15%).
Why Apply?
* High-impact role supporting regulatory compliance and market expansion across EMEA.
* Opportunity to work closely with global stakeholders and regulatory leaders.
* Flexible UK-based remote/hybrid model.
* Competitive hourly rate and long-term contract stability.
How to Apply
If you’re ready to take the next step in your Regulatory Affairs career and make a meaningful impact on product compliance and market access, we’d love to hear from you.
Apply today and become part of a team driving high‑quality regulatory excellence across the EMEA region.