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Director Quality Assurance Regulatory Affairs, stoke-on-trent
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Client:
Location:
stoke-on-trent, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Views:
4
Posted:
12.05.2025
Expiry Date:
26.06.2025
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Job Description:
Director of Quality & Regulatory Affairs – Class III Medical Devices
Location: Near Stoke on Trent (Hybrid – Onsite 3 days/week)
Sector: Medical Devices - Class III | Global Markets
A leader in the development and manufacturing of cutting-edge, medical device business is seeking an experienced Director of Quality & Regulatory Affairs to join their senior leadership team. This is a pivotal role in a company committed to saving lives through innovation and rigor in medical device development.
Key Responsibilities:
* Lead and evolve the global Quality & Regulatory strategy across a high-performing portfolio of Class IIb and III medical devices.
* Spearhead the preparation, authorship, and submission of FDA 510(k) applications, ensuring compliance with U.S. regulatory pathways.
* Direct the successful transition from MDD to MDR, with robust oversight of ongoing EU regulatory compliance.
* Oversee the implementation and continual improvement of a harmonized Quality Management System aligned with ISO 13485 and FDA regulations.
* Collaborate with Clinical Affairs to support clinical evaluations, PMCF activities, and study oversight.
* Engage with cross-functional stakeholders including R&D, manufacturing, and commercial to drive quality, compliance, and strategic outcomes.
* Act as a senior decision-maker, influencing long-term direction and mentoring the broader quality and regulatory team.
Key Requirements:
* Proven experience managing regulatory submissions, particularly FDA 510(k), with successful outcomes.
* Demonstrated expertise in MDR compliance and navigating complex EU regulatory landscapes.
* Deep knowledge of ISO 13485 and FDA Quality System Regulation (QSR).
* Involvement in clinical affairs, ideally with exposure to clinical evaluations and post-market follow-up strategies.
* Background working with Class III or high-risk Class IIb medical devices.
* Strong leadership presence with a track record of guiding diverse, cross-functional teams.
* Willingness to be onsite in Crewe at least three days per week.
Why Join?
This is more than a regulatory role—it’s an opportunity to influence the direction of life-saving medical technology used by defense forces, first responders, and healthcare providers globally. You’ll be part of a mission-driven organisation where innovation and compliance go hand in hand.
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