Quality and Compliance Lead
1 week ago
X4 Life Sciences is a London-based start-up medical device company developing a Class 1 Measuring Device. We are seeking a Quality and Compliance Lead to assist with all things QARA.
Responsibilities:
- Developing and executing regulatory strategies for FDA clearance, followed by other markets.
- Installing and maintaining a QMS compliant with ISO 13485 and CFR21 Part 820.
- Overseeing internal audits and managing external inspections by notified bodies and regulatory authorities.
- Managing regulatory documentation, including submission dossiers, technical files, and risk management files.
Requirements:
- Proven experience in QARA, including preparing and submitting regulatory submissions.
- Familiarity with global medical device regulations, including CFR 21, EU MDR and UKCA.
- Experience with common international standards for electronic medical devices (ISO 13485, 14971, 10933, 60601).
Benefits:
- A competitive salary of £60,000 - £65,000 per annum.
- An opportunity to work with a dynamic and growing company in the medical device industry.
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