Regulatory Affairs and Quality Assurance Specialist

2 months ago


Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time
About the Role

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
  • Provide quality assurance and regulatory affairs advice on the creation of new products and the improvement of existing technologies.
  • Work closely with the R&D team to provide vital advice on the creation of medical devices, ensuring compliance with FDA 510k, ISO 13485, and FDA 21 CFR Part 820 standards.
  • Assist in the preparation of regulatory submissions and ensure that all necessary documentation is completed accurately and on time.
  • Collaborate with the Quality Assurance and Regulatory Affairs Manager to develop and implement quality management systems (QMS) and ensure their effective implementation.
  • Conduct audits and assessments to ensure compliance with regulatory requirements and industry standards.
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 quality management systems (QMS) is highly desirable.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
  • Strong analytical and problem-solving skills, with the ability to interpret complex data and make informed decisions.
What We Offer

We offer a competitive salary, excellent benefits package, and the opportunity to work on life-improving devices. As a growing company, we are committed to providing career progression opportunities and a dynamic work environment.



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