Regulatory Affairs Officer

• Type: Permanent

Regulatory Affairs Officer

The Company:

UK manufacturer of single use medical devices

Global reach

Outstanding reputation for service and product quality



Benefits of the Regulatory Affairs Officer:

• £30k basic salary
• Death in Service (2 x Salary)
• Employer Pension @ 5% employer + 5% employee
• 23 Days annual leave + bank holidays
• Health Shield - Employee Health Cash Plan
• Perkbox

The Role of the Regulatory Affairs Officer:

Our client is a leading medical devices manufacturer. You will cover and maintain the QA/RA system in accordance with the latest relevant standards for the product ranges produced.

Responsibilities include:

1. Assist in registration of devices with worldwide regulatory bodies and collate the necessary information.
2. Comprehensive understanding of regulatory requirements applicable to the company.
3. Ensure technical documentation is maintained and reviewed regularly against all regulatory standards.
4. Ensure Declarations of Conformity are kept up to date.
5. Maintain all information on the MHRA website.
6. Liaise with the Quality department on aspects of quality related documentation where required.
7. Work alongside New Product Development in the process of incorporating new products into the business, ensuring all relevant documentation is available and stored in the correct areas.
8. Update any relevant databases as assigned.
9. Ensure naming conventions are consistent throughout all documentation.
10. Cover for other areas in the department when required.
11. Any other tasks that are deemed necessary to fulfil the job role to the satisfaction of the company objectives.

The Ideal Person for the Regulatory Affairs Officer:

This is a junior role with a clear progression path. Would suit someone at the early stages of their RA career or a fresh graduate with an interest in RA. Desired qualities include:

1. Strong attention to detail.
2. Effective cross-functional communication and cooperation.
3. Desire to learn and focus on continued professional development.
4. Be a positive influence on team morale.

If you think the role of Regulatory Affairs Officer is for you, apply now!

Consultant: David Gray
Email: davidg@otrsales.co.uk
Tel no.: 0208 397 4114

Candidates must be eligible to work and live in the UK.

• Start: ASAP
• Duration: Full-Time