Quality Assurance and Regulatory Affairs Coordinator

16 hours ago


Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

Newton Colmore Consulting Ltd is a leading recruitment specialist in Medical Devices, Science, and Biotech. We are looking for a talented Regulatory Affairs and Quality Assurance Assistant to join our team. This role involves supporting the Quality Assurance and Regulatory Affairs Manager in ensuring compliance with industry standards and regulations.

Responsibilities Include:

  • Providing quality assurance and regulatory affairs advice on new product development and existing technology improvements
  • Collaborating with the R&D team to ensure compliance with FDA 510k, ISO 13485, and FDA 21 CFR Part 820 standards
  • Communicating effectively with teams responsible for writing submissions

Requirements and Qualifications:

  • Bachelor's degree in an engineering or science-related field
  • Experience in regulatory affairs or quality assurance, preferably in the medical devices sector
  • Strong knowledge of QMS principles and practices

Compensation and Benefits:

  • An annual salary range of £45,000-£60,000, based on experience
  • A comprehensive benefits package, including career development opportunities and share options


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