Head of Quality and Regulatory Affairs
3 weeks ago
ProTech Recruitment Ltd is seeking a highly skilled and motivated Head of Quality and Regulatory Affairs to join their team. This individual will play a critical role in guiding the organisation's innovative medical products through the regulatory approval process, ensuring compliance with global quality standards.
This is an exciting opportunity for someone who is passionate about navigating complex regulatory landscapes to bring cutting-edge technologies to market.
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.
- Serve as the key point of contact for communications with regulatory bodies and Notified Bodies.
Requirements:
- Demonstrable experience with successful regulatory submissions, including FDA, UKCA, and CE marking applications for in vitro diagnostics.
- Strong knowledge of global regulatory requirements and standards.
- Excellent communication and leadership skills.
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