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Senior Regulatory Affairs Specialist

4 weeks ago

London, Greater London, United Kingdom Newton Colmore Full time

Job Title: Senior Regulatory Affairs Specialist

Job Summary:

We are seeking a highly experienced Senior Regulatory Affairs Specialist to join our team at Newton Colmore. As a Senior Regulatory Affairs Specialist, you will be responsible for managing regulatory affairs standards and quality management systems on our brand new IVD technology.

Key Responsibilities:

  • Assist with the management of regulatory affairs standards and quality management systems on our IVD technology.
  • Work closely with the quality assurance and design teams to ensure the success of the product.
  • Steer future R&D pipeline and ensure compliance with regulatory standards within the UK and Europe.
  • Undertake internal audits and ensure that all regulatory standards are met.

Requirements:

  • Strong knowledge of regulatory standards within the UK and Europe.
  • Experience in the IVD market and FDA submissions.
  • Ability to work in a ISO 13485 environment.
  • Excellent communication and interpersonal skills.

About Us:

Newton Colmore is a growing medical devices company in London. We are committed to developing life-saving and life-improving medical devices.