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Director of Quality and Regulatory - Medical Device, Sunbury-on-Thames
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Client:
Page Personnel
Location:
Sunbury-on-Thames, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
4f9eb32c0853
Job Views:
6
Posted:
25.08.2025
Expiry Date:
09.10.2025
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Job Description:
* Contribute to a therapy area that changes lives
* Join an excellent team of leaders
About Our Client
Our client is a medical device developer and manufacturer, supplying clinics worldwide
Job Description
* Represent role model or servant leader model leadership as a member of senior site management team.
* Develop and implement the QARA strategy aligned with business goals and regulatory compliance requirements.
* Collaborate with Engineering, Operations, and Commercial teams to integrate quality and compliance from concept to delivery.
* Oversee global product registrations and submissions, including CE marking and international approvals for UK products.
* Support in defining regulatory pathways early in product development, including Intended Use and Risk Classification.
* Ensure compliance with ISO 13485, MDR, FDA 21 CFR Part 820, and other relevant standards.
* Maintain and enhance the Quality Management System (QMS).
* Lead internal and supplier audits, investigations, and corrective actions.
* Analyse QA data to drive continuous improvement and risk mitigation.
The Successful Applicant
- Extensive experience in a 13485 setting - Extensive knowledge of MDR and FDA Regulations - Strong leadership track record
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