Job Description 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:
Lead new registrations into new markets, EU, US, ROW
Drive global RA and Quality strategies
Ensure that all technical documentation is kept up to date
Manage company wide compliance with ISO13485, IVDD, IVDR, FDA and Canadian Medical Device Regulations, and other global regulations
Interpret complex legislation and deliver advice to various team members
Assist with the implementation of the Company's Quality Policy
Lead pr...