Job Title: Regulatory Affairs Team Lead – IVDs
Company:
Cpl Life Sciences
Location:
Outskirts of Edinburgh, Scotland, UK – 3x a week on site.
Job Type:
Full-Time, permanent position, 37.5 hours per week.
Description:
An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. As a Regulatory leader, you will be responsible for leading the team and ensuring continuous improvements within the Regulatory function.
You will support and lead all areas of Regulatory Affairs from development through to post-market surveillance, driving global strategies, and must be experienced within diagnostics/Medical Devices.
Responsibilities:
* Lead new registrations into new markets (EU, US, ROW)
* Drive global Regulatory Affairs and Quality strategies
* Ensure all technical documentation is up to date
* Manage company-wide compliance with ISO 13485, IVDD, IVDR, FDA, Canadian Medical Device Regulations, and other global regulations
* Interpret complex legislation and advise team members
* Assist with implementing the company's Quality Policy
* Lead projects including product license applications
* Compile and submit registration/approval submissions in international markets
Key Requirements:
* A scientific degree and at least 7+ years of experience in areas including but not limited to US regulatory applications and EU CE marking (IVDD/IVDR)
* Must have the full right to work in the UK; relocation may be offered for the right candidate
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