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Regulatory Affairs Specialist
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Head of Quality and Regulatory Affairs
2 months ago
We are seeking a highly skilled and motivated Head of Quality and Regulatory Affairs to join our team at JobLookup. This individual will play a critical role in guiding our organisation's innovative medical products through the regulatory approval process, ensuring compliance with global quality standards.
Key Responsibilities- Develop and execute the regulatory strategy for all products across key international markets.
- Provide regulatory guidance and training to the team on global regulatory changes.
- Lead the preparation and submission of regulatory applications, including FDA approvals, UKCA, and CE marking.
- Ensure post-market surveillance activities comply with all regulatory requirements.
- Manage external relations with regulatory bodies, Notified Bodies, and reimbursement entities.
- Achieve and maintain ISO13485 certification, ensuring full compliance with quality standards.
- Oversee the company's QMS, ensuring all staff are trained on and adhere to quality procedures.
- Lead both internal and external audits to ensure ongoing compliance.
This is an exceptional opportunity to drive the regulatory and quality functions of a company at the forefront of healthcare innovation. Ideal candidates will be passionate about bringing life-changing products to market while ensuring the highest regulatory and quality standards.
