Regulatory Affairs Team Lead

Job Title: Regulatory Affairs Team Lead – IVD’s

Job Type: Full-Time, permanent position

Location: Outskirts of Edinburgh, Scotland, UK – 3x a week on site.

Remuneration: Competitive benefits package

The role is a full-time, permanent position working 37.5 hours per week.

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.

Supporting and leading all areas of Regulatory Affairs from development through to post-market surveillance, you will be driving global strategies and MUST be experienced within diagnostics/Medical Devices.

Responsibilities:

1. Lead new registrations into new markets, EU, US, ROW
2. Drive global RA and Quality strategies
3. Ensure that all technical documentation is kept up to date
4. Manage company-wide compliance with ISO13485, IVDD, IVDR, FDA and Canadian Medical Device Regulations, and other global regulations
5. Interpret complex legislation and deliver advice to various team members
6. Assist with the implementation of the Company's Quality Policy
7. Lead projects including product license applications
8. Compile and submit initial registration/approval submissions in international markets

Key Requirements:

1. A scientific degree and at least 7+ years of experience are needed, covering areas including but not limited to:
2. US regulatory applications and EU CE marking (IVDD/IVDR)
3. Post-market surveillance
4. Medical device manufacturing
5. Managerial and leadership experience

You MUST hold the full right to work in the UK; this role may offer relocation for the right candidate.