Senior Regulatory Affairs Specialist
Company: SRG Agency
- Location: Cheshire West And Chester, United Kingdom
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Senior Regulatory Affairs Specialist / RA Lead
Shape strategy. Drive approvals. Make a global impact.
Are you an experienced Regulatory Affairs professional looking for a role where you can influence strategy, work on complex medical technologies, and play a key part in bringing innovative products to patients worldwide?
We're looking for a Senior Regulatory Affairs Specialist to join a collaborative and forward-thinking team, supporting products across the full lifecycle, from development and market approval through to post-market activities. You'll have the opportunity to work on a diverse product portfolio, including Class III medical devices, while partnering with senior stakeholders to navigate complex global regulatory requirements.
This is more than a submissions role. You'll be a trusted regulatory expert, helping to shape strategy, review critical documentation, and guide project teams through evolving regulatory landscapes.
What You'll Be Doing
- Help define and deliver regulatory strategies that support product development and global market access.
- Review and approve key regulatory documents, including Technical Documentation, Clinical Evaluation Reports (CERs), and submission dossiers.
- Lead and support submissions across major markets, including EU MDR, US FDA 510(k), and other international registrations.
- Provide regulatory expertise on classification, clinical evidence requirements, and conformity assessment pathways.
- Act as a key partner to cross-functional teams, influencing decisions and supporting project success.
- Support regulatory authority interactions, audits, inspections, and responses to agency questions.
- Stay ahead of regulatory developments and assess their impact on products and business activities.
- Coach and support colleagues, sharing knowledge and helping to strengthen regulatory capability across the team.
What We're Looking For
- Proven experience in Regulatory Affairs within the medical device industry.
- Strong knowledge of EU MDR and US FDA regulations, including Technical Documentation and 510(k) submissions.
- Experience contributing to regulatory strategy alongside hands-on submission and compliance activities.
- Exposure to international registrations across multiple global markets.
- Understanding of Clinical Evaluation, Post-Market Surveillance (PMS), and Post-Market Clinical Follow-Up (PMCF) activities would be advantageous.
- A confident communicator who can build relationships and influence stakeholders at all levels.
Why Join?
- Work on innovative medical technologies that make a genuine difference to patients' lives.
- Take ownership of high-impact regulatory activities across global markets.
- Influence regulatory strategy and business decisions.
- Collaborate with experienced professionals in a supportive and knowledge-sharing environment.
- Enjoy opportunities for professional growth, development, and increased responsibility.
If you're looking for a role that combines strategic influence, technical expertise, and global exposure, we'd love to hear from you.
