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Senior Regulatory Affairs Specialist
Job Posted: 5 days ago
Salary: £ 45,000 - 55,000 / Annum
Job Type: Permanent
Location: CW1, Crewe, Cheshire East
Expire in: 23 days
Job Description
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 youBefore You Apply
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Looking for your next career move? Join a top company hiring Senior Regulatory Affairs Specialist job near me in CW1, Crewe, Cheshire East! This is your chance to work on exciting projects, grow professionally, and enjoy a rewarding career with competitive pay and excellent benefits. Whether you're an experienced professional or looking to take the next step, this role offers the perfect opportunity to enhance your skills and make an impact. Don’t miss out—apply today via Vita CV and take your career to the next level!
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