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Head of Quality and Regulations

Head of Quality and Regulations


Lead/Head of Quality and Regulations
Location: Cambridge, UK
Salary: Competitive compensation package
Reports to: CEO
Job summary: We are partnering with a high-growth digital in-vitro diagnostic start-up looking for a Lead/Head of Quality and Regulations to join their expanding team. You will be manging and developing the Quality Management Systems and ensuring compliance with ISO 13485 standard. You will be a member of the senior team working closely with the CEO to drive company growth.  If you enjoy working in a fast-paced dynamic environment and have a passion for digital technologies, then this role would be a perfect fit.
Key Responsibilities

  • Management and development of the company’s Quality Management System (QMS) in compliance with ISO 13485
  • Management and development of the company’s existing TF’s for CE, FDA and UKCA marking
  • Maintain and improve upon existing standard operating procedures (SOPs)
  • Ensure records and references within QMS are kept up-to-date and are fully traceable
  • Ensure organization meets regulatory obligations throughout the full product lifecycle
  • Accountable for internal and external audits
  • Maintenance of the company’s Internal Audit program
  • Management of the change control process
  • Provide guidelines, support, and training to staff in the operation of quality assurance and control methods
  • Ensure effective coordination and implementation of regulatory activities in support of product development, registration, lifecycle management and maintenance
  • Update Technical Files for submission to healthcare regulatory agencies internationally
  • Work with the Commercial team to prepare marketing applications in new territories
  • Accountable for regulatory compliance for defined projects, brands and/ or portfolio including, but not limited to, new and existing products, packaging, and communications
  • Manages Regulatory Agency and submissions, as required
  • Monitor the industry landscape with a particular focus on new regulations and relevant litigation

Qualifications & Experience Required

  • Minimum 5 years’ experience working in Quality and Regulatory roles within diagnostic or medical device companies.
  • Proficiency in quality systems (ISO 13485), associated documentation.
  • Excellent knowledge of the in-vitro diagnostic industry and regulations (IVDD and IVDR).
  • Experience in bringing IVDs to market.
  • Experience of working in start-up environments a plus.
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Job Overview
Offered Salary
50000 – 80000/Year