Regulatory Affairs Specialist

2 months ago


Stirling, United Kingdom CW Recruitment Specialists Full time

In this role you will support the RA Manager with regulatory submissions and compliance activities support the business and its expansion and growth.

The main duties include:

- Assist in the design and development of clinical trial activities.
- Provide regulatory and scientific advice to other areas of the Organization.
- Develop regulatory affairs internal policies and procedures, and provide training as and when required.
- Review changes in manufacturing for regulatory effects and compliance with applicable regulations.
- Participate in company regulatory/quality audits.
- Identify regulatory requirements for new product and changes to existing products & markets.
- Contribute within new product development projects to provide ongoing regulatory guidance and ensure compliance with relevant regulatory requirements.
- Review labelling/marketing material for compliance with applicable regulations and standards.
- Support post-market surveillance and vigilance activities, including submitting reports to authorities.
- Review new and existing regulations, guidance documents & Standards, and prepare comments based on impact to product and business.

**Salary**: £30,000.00-£50,000.00 per year

**Benefits**:

- Company pension
- Flexitime
- On-site gym
- On-site parking

Schedule:

- Flexitime
- Monday to Friday

Work Location: In person

Reference ID: RA Specialist

Flextime



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