Quality and Regulatory Specialist

Quality Assurance & Regulatory Affairs Specialist

Location: Buckinghamshire

Salary: £40,000-£60,000 (dependent on experience)

Our client is an established life sciences business based in Buckinghamshire. They distribute and manufacture high-quality and innovative products, including in-vitro diagnostics, laboratory reagents, and biological materials, across the European life sciences market.

An opportunity has become available for an experienced Quality Assurance and Regulatory Affairs Specialist to join the company on a permanent basis.

This is an onsite position so the successful applicant will be expected to be on site full-time.

The Role:

This is a key role within the Quality and Regulatory team The core responsibility is to act as the responsible person for the Company ISO 9001, ISO 13485 and ISO 14001 Environmental Management Systems, and ensure the continuous improvement in the quality and environmental standards of the company.

• Implementing quality and regulatory directives to ensure compliance
  
  
• Maintaining the company's Quality Management Systems (QMS) in line with ISO 9001, ISO 13485, and ISO 17025
  
  
• Ensuring regulatory compliance for in vitro diagnostics – IVDD/IVDR and CE marking
  
  
• Scheduling audits in accordance with ISO 13485, ISO 9001, and ISO 17025
  
  
• Supporting with the management of non-conformities and deviations
  
  Suitable Applicants:
  
  Given the responsibilities of this role, we are seeking a candidate with prior industry experience in a Quality and Regulatory position, within the Medical Device or Diagnostics sector.
  
  Key requirements are:
  
  
• Proven experience in the maintenance of Quality Management Systems
  
  
• In-depth knowledge of ISO 13485, ISO 9001, and ISO 17025
  
  
• Experience with ISO-accredited audits
  
  
• Prior experience with Environmental Management Systems
  
  In return, our client offers the opportunity to join the company on a permanent basis in a pivotal role. The position offers a salary of circa £40,000-£60,000(dependent on experience), along with benefits