Regulatory Affairs and Quality Assurance Specialist

19 hours ago


Edinburgh, Edinburgh, United Kingdom Clinical Professionals Limited Full time

Estimated Salary: £50,000 - £70,000 per annum

About the Role

Clinical Professionals Limited is seeking an experienced Regulatory Affairs and Quality Assurance Specialist to join our team in Edinburgh.

Job Description

We are looking for a highly skilled individual to support our growing Regulatory Affairs Department. As a Regulatory Affairs and Quality Assurance Specialist, you will be responsible for delivering regulatory packages under ODM-Distributor schemes, overseeing initial compilation of design control evidences, supplier management, incoming inspection and product release processes, product submissions, post-market surveillance, vigilance, and associated reporting.

You will also be responsible for maintaining product and site regulatory and quality compliance, ensuring license/registration is maintained once granted. Additionally, you will provide guidance and training to other regulatory and quality affairs team members as needed.

The ideal candidate will have a Master's degree or equivalent in life sciences and 3-5 years of experience in a regulatory/quality role. Significant specialist knowledge of regulations applied to medical devices, IVDs, or biologics is required.

This is a permanent position, with a negotiable salary based on experience. The location is the outskirts of Edinburgh, with a hybrid working arrangement (three days a week in the office).

Key Responsibilities:
  • Deliver regulatory packages under ODM-Distributor schemes
  • Oversee initial compilation of design control evidences, supplier management, and incoming inspection and product release processes
  • Maintain product and site regulatory and quality compliance
  • Provide guidance and training to other team members
  • Prepare and compile regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations, Medical Device Approvals, and other country requirements
Requirements:
  • Master's degree or equivalent in life sciences
  • 3-5 years of experience in a regulatory/quality role
  • Significant specialist knowledge of regulations applied to medical devices, IVDs, or biologics
Working Arrangements:

Three days a week in the office, located on the outskirts of Edinburgh. Hybrid working arrangements available.



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