Job Title: Regulatory Affairs Team Lead – IVDs
Job Details
* Type: Full-Time, Permanent
* Location: Outskirts of Edinburgh, Scotland, UK – 3 days on-site per week
* Remuneration: Competitive benefits package
* Working hours: 37.5 hours per week
Company Overview
Join an established and growing IVD manufacturer, supporting a dynamic Regulatory Affairs Department. As a Regulatory leader, you will oversee team operations and drive continuous improvements within the Regulatory function.
Responsibilities
1. Lead new registrations in markets such as EU, US, and ROW
2. Drive global Regulatory Affairs and Quality strategies
3. Maintain up-to-date technical documentation
4. Manage compliance with ISO, IVDD, IVDR, FDA, Canadian Medical Device Regulations, and other global standards
5. Interpret complex legislation and advise team members accordingly
6. Support the implementation of the company's Quality Policy
7. Lead projects including product license applications
8. Prepare and submit registration/approval dossiers internationally
Key Requirements
1. Scientific degree with 7+ years of relevant experience
2. Experience with US regulatory applications and EU CE marking (IVDD/IVDR)
3. Managerial and leadership skills
4. Full right to work in the UK (relocation assistance may be provided)
Additional Information
For more details, please contact us. This role requires compliance with EU work permit regulations.
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