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Regulatory Affairs Officer

On Target Recruitment Ltd

Newcastle upon Tyne, Gateshead, Sunderland

On-site

GBP 30,000

Full time

29 days ago

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An established industry player is seeking a Regulatory Affairs Officer to join their team. This junior role offers a clear progression path, ideal for early-career professionals or recent graduates interested in regulatory affairs. The successful candidate will be responsible for maintaining the QA/RA system, ensuring compliance with regulatory standards, and assisting in the registration of medical devices. With a strong emphasis on attention to detail and effective communication, this position provides an excellent opportunity to develop your skills in a supportive environment. If you're eager to learn and make a positive impact, this role is for you.

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

Ideal for early-stage RA professionals or fresh graduates.
Focus on attention to detail and effective communication.

Assist in device registration with regulatory bodies.
Maintain QA/RA system and ensure compliance with standards.
Liaise with Quality department on documentation.

Attention to Detail

Cross-functional Communication

Desire to Learn

Degree in a relevant field

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:

Assist in registration of devices with worldwide regulatory bodies and collate the necessary information.
Comprehensive understanding of regulatory requirements applicable to the company.
Ensure technical documentation is maintained and reviewed regularly against all regulatory standards.
Ensure Declarations of Conformity are kept up to date.
Maintain all information on the MHRA website.
Liaise with the Quality department on aspects of quality related documentation where required.
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.
Update any relevant databases as assigned.
Ensure naming conventions are consistent throughout all documentation.
Cover for other areas in the department when required.
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:

Strong attention to detail.
Effective cross-functional communication and cooperation.
Desire to learn and focus on continued professional development.
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.