Regulatory Affairs and Quality Assurance Specialist
19 hours ago
Estimated Salary: £50,000 - £70,000 per annum
About the RoleClinical Professionals Limited is seeking an experienced Regulatory Affairs and Quality Assurance Specialist to join our team in Edinburgh.
Job DescriptionWe 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
- 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
Three days a week in the office, located on the outskirts of Edinburgh. Hybrid working arrangements available.
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