Head of Quality and Regulatory Affairs Specialist
1 month ago
Regulatory and Quality Assurance Leadership Opportunity
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.
The ideal candidate will have demonstrable experience with successful regulatory submissions, including FDA, UKCA, and CE marking applications for in vitro diagnostics. They will be responsible for leading the regulatory strategy for all products across key international markets, providing regulatory guidance to the team, and overseeing the preparation and submission of regulatory applications. Additionally, they will ensure post-market surveillance activities comply with all regulatory requirements and manage external relations with regulatory bodies, Notified Bodies, and reimbursement entities.
Key Responsibilities:
- Develop and Execute Regulatory Strategy: Lead the development and execution of the regulatory strategy for all products across key international markets.
- Provide Regulatory Guidance: Ensure the team is up-to-date on global regulatory changes and provide training on regulatory requirements.
- Oversee Regulatory Submissions: Lead the preparation and submission of regulatory applications, including FDA approvals, UKCA, and CE marking.
- Ensure Post-Market Compliance: Ensure that post-market surveillance activities comply with all regulatory requirements.
- Manage External Relations: Serve as the key point of contact for communications with regulatory bodies, Notified Bodies, and reimbursement entities.
Quality Management Responsibilities:
- Achieve ISO13485 Certification: Lead the process to gain and maintain ISO13485 certification, ensuring full compliance with quality standards.
- Oversee Quality Management System (QMS): Oversee the company's QMS, ensuring that all staff are trained on and adhere to quality procedures.
- Lead Audits: 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.
Please note: We are unable to accept applicants who require sponsorship.
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