Senior Regulatory Affairs Specialist

3 weeks ago


Cheshire, United Kingdom Cast UK Limited Full time

**Senior Regulatory Affairs Specialist
Cheshire
£ Competitive Salary**

**Role Profile**

Our client is a highly successful medical device business based in Cheshire. They are currently looking to appoint a Senior Regulatory Affairs Specialist to provide regulatory expertise in the research, development and marketing of products.

The key purpose of the role will be to ensure regulatory approvals are achieved and maintained in in accordance with agreed company objectives.

**Key responsibilities will include**:

- To provide ongoing regulatory advice to project teams throughout the product and process development
- Interpret individual country legislation relevant to the project and business units
- Liaise with external regulatory authorities to ensure approvals are obtained in line with business plans
- To compile, review and approve regulatory submissions in accordance with the national requirements

**Skills and Experience**
- Degree, or equivalent qualification, in a Life Science, or equivalent industry experience
- Atleast 3 years' experience within regulatory environment or equivalent regulatory compliance function.
- Understanding of ISO14971 Risk Management within a Medical Device industry
- Knowledge of relevant GMP and Quality Systems standard, specifically with FDA Quality System Regulation and ISO 13485

**Client**

Our client is a highly successful medical device business based in Cheshire. The business has continued to see growth year on year and is a key player in its market.

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