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Quality Manager and Regulatory Affairs

2 months ago

Cambridge, United Kingdom ProTech Recruitment Ltd Full time
Head of Quality and Regulatory Affairs
A fast growing healthcare technology company is looking for 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.
You must have demonstrable experience with successful regulatory submissions, including FDA, UKCA, and CE marking applications for in vitro diagnostics.
Lead Regulatory Strategy: Develop and execute 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 train team members on regulatory requirements.
Oversee Submissions: Lead the preparation and submission of regulatory applications, including FDA approvals, UKCA, and CE marking.
Post-Market Compliance: Ensure that post-market surveillance activities comply with all regulatory requirements.
Serve as the key point of contact for communications with regulatory bodies, Notified Bodies, and reimbursement entities.Additionally, the Head of Quality will manage the company's quality systems, including:
Achieve ISO13485 Certification: Lead the process to gain and maintain ISO13485 certification, ensuring full compliance with quality standards.
Quality Management System (QMS): Oversee the company's QMS, ensuring that all staff are trained on and adhere to quality procedures.
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.