Director of Quality Assurance and Compliance

1 day ago


Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full time

Head of Regulatory Compliance

A fast-growing healthcare technology company is seeking a highly skilled Director of Quality Assurance and Compliance to drive regulatory compliance across international markets. This individual will play a pivotal role in guiding the organization's innovative medical products through the regulatory approval process, ensuring adherence to 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.

  1. Lead Regulatory Strategy: Develop and execute a comprehensive regulatory strategy for all products across key international markets.
  2. Provide Regulatory Guidance: Ensure the team remains up-to-date on global regulatory changes and provide training on regulatory requirements.
  3. Oversee Submissions: Lead the preparation and submission of regulatory applications, including FDA approvals, UKCA, and CE marking.
  4. Post-Market Compliance: Ensure that post-market surveillance activities comply with all regulatory requirements.
  5. Manage External Relations: Serve as the primary point of contact for communications with regulatory bodies, Notified Bodies, and reimbursement entities.
Quality Management Responsibilities:
  1. Achieve ISO13485 Certification: Lead the process to gain and maintain ISO13485 certification, ensuring full compliance with quality standards.
  2. Quality Management System (QMS): Oversee the company's QMS, ensuring that all staff are trained on and adhere to quality procedures.
  3. Audit Leadership: Lead both internal and external audits to ensure ongoing compliance.
About ProTech Recruitment Ltd

We are a leading recruitment agency specializing in placing top talent in the healthcare technology industry. We pride ourselves on building long-lasting relationships with our clients and candidates alike. If you're passionate about bringing life-changing products to market while ensuring the highest regulatory and quality standards, we'd love to hear from you

Salary Information

The estimated salary for this position is £80,000-£110,000 per annum, depending on experience.

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