Senior Regulatory Affairs Specialist

Cure Talent are delighted to be partnered with a global medical device company recognised for its life-saving technologies. As they continue to expand their portfolio and international presence, we have an exciting opportunity for a Senior Regulatory Affairs Specialist to join their growing team.

As the new Senior RA Specialist, you will play a key role in leading complex regulatory submissions and maintaining approvals across global markets. Acting as a senior member of the team, you will provide expert regulatory guidance across product development, lifecycle management, and post-market activities, while supporting audits, inspections and mentoring colleagues.

Key Responsibilities

• Lead the preparation and maintenance of global submissions, including EU MDR, UKCA, FDA and international approvals.
• Provide advanced regulatory advice to cross-functional teams throughout product and process development.
• Review and approve design changes, labelling, artwork and promotional material for compliance.
• Monitor evolving global regulatory requirements and communicate impact across the business.
• Represent Regulatory Affairs during audits, inspections and external authority interactions.

Experience and Skills Required

• Proven Regulatory Affairs experience within the medical device sector.
• Experience with Wound Care and/or Class III Devices is highly advantageous Proven track record with EU MDR, FDA and other global submissions.
• Strong knowledge of ISO 13485, ISO 14971, GMP and regulatory frameworks.
• Experience supporting or hosting regulatory inspections and audits.

 If you’re an experienced Regulatory Affairs professional seeking a senior-level opportunity to take ownership of global submissions and play a central role in shaping regulatory strategy, we’d love to hear from you.