Regulatory Affairs and Quality Assurance Specialist

2 weeks ago


Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time
Regulatory Affairs and Quality Assurance Assistant - Medical Devices

We are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our medical devices team, you will work closely with our Quality Assurance and Regulatory Affairs Manager to ensure compliance with regulatory requirements.

  • Key Responsibilities:
  • Provide expert advice on new product creation and technology improvement, ensuring compliance with regulatory standards.
  • Collaborate with cross-functional teams to develop and implement quality management systems.
  • Conduct thorough risk assessments and develop mitigation strategies to ensure product safety and efficacy.
  • Requirements:
  • Proven knowledge of design processes and medical devices regulations, including ISO 13485 and FDA 510k.
  • Strong understanding of quality management systems and regulatory compliance.
  • Desirable:
  • Experience working in a medical devices company, with a strong understanding of industry trends and regulations.
  • 1st or 2:1 degree in an engineering or sciences discipline.
  • What We Offer:
  • A competitive salary and benefits package.
  • Opportunities for career progression and professional development.
  • The chance to work on industry-changing products and contribute to the growth of our company.


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