Senior Regulatory Affairs Specialist

4 weeks ago


London, Greater London, United Kingdom Newton Colmore Consulting Ltd 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 Consulting Ltd. 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
  • Work closely with the quality assurance and design teams to ensure the success of the product
  • Undertake internal audits to ensure compliance with regulatory standards
  • Develop and implement regulatory strategies to ensure compliance with UK and European regulations

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 project management skills

About Us:

Newton Colmore Consulting Ltd is a specialist recruitment company within the Medical Devices, Scientific Engineering, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance and Field Service Engineering sectors.



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