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Regulatory Affairs Specialist

2 months ago


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

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 play a crucial role in ensuring the quality and regulatory compliance of our clients' products.

Key Responsibilities:
  • Assist in the development and implementation of quality management systems (QMS) and regulatory strategies for medical devices.
  • Provide quality assurance and regulatory affairs advice on the creation of new products and the improvement of existing technologies.
  • Collaborate with the R&D team to provide vital advice on the creation of medical devices and ensure compliance with FDA 510k, ISO 13485, and FDA 21 CFR Part 820 standards.
  • Support the preparation and submission of regulatory documents, including FDA 510k and CE marking applications.
  • Conduct research and analysis to stay up-to-date with regulatory requirements and industry developments.
Requirements:
  • Bachelor's degree in an engineering or sciences discipline.
  • Experience in regulatory affairs or quality assurance, preferably in the medical devices sector.
  • Knowledge of design processes and QMS principles.
  • Excellent communication and problem-solving skills.
What We Offer:
  • A competitive salary and benefits package.
  • Opportunities for career progression and professional development.
  • A dynamic and supportive work environment.
  • The chance to work on life-improving devices and contribute to the growth of a successful company.