Regulatory Affairs Specialist

Selexa Biotech are partnered with an innovative Medical Devices client in Cambridgeshire, who are looking to grow their newly reformed QARA function with additional Regulatory Affairs Specialists.

You will provide guidance and support across the Regulatory Affairs function, including planning, coordinating & managing Regulatory documents, reviewing and compiling medical device files and liaising with Regulatory authorities to support regulatory submissions and vigilance activities.

**Requirements Include**:

- Relevant degree in Engineering, Life Sciences, Biomedical Engineering
- 1-2 years experience within Regulatory Affairs within medical devices
- Working knowledge of applicable domestic and international guidelines, policies and regulation
- Knowledge and experience with pre
- & post-market medical device regulations

**Salary**: £30,000.00-£42,000.00 per year

**Benefits**:

- Flexitime
- Work from home

Schedule:

- Flexitime
- Monday to Friday

Ability to commute/relocate:

- Ely: reliably commute or plan to relocate before starting work (required)

**Experience**:

- Regulatory Affairs: 1 year (preferred)

Work Location: One location

Reference ID: LBRASCE

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