This range is provided by Cure Talent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
Overview
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.
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.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance, Legal, and Engineering
Industries
* Medical Equipment Manufacturing
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.
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