Regulatory Affairs Officer

Job Title: Regulatory Affairs Officer
Location: Washington, Tyne and Wear
Salary: Competitive, based on experience
Benefits: Pension scheme, flexitime, career development support, and more

The Company:
Join a dynamic and forward-thinking manufacturer with a global footprint. This organisation is dedicated to innovation, quality, and compliance — with an emphasis on personal development and a collaborative working culture. As they continue to grow and develop new products, they are looking for a Regulatory Affairs Officer to strengthen their Regulatory Affairs team.

Working Hours:
Monday to Friday, 08:30 – 16:30
Flexitime policy with up to 2 days in credit or 1 day deficit

Benefits:

Competitive salary

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Professional development opportunities

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Supportive team environment

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Company pension scheme

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Flexitime with work-life balance

Job Description:
As a Regulatory Affairs Officer, you will play a vital role in supporting and maintaining the company’s Quality Assurance and Regulatory Affairs (QA/RA) system in line with the latest standards and regulations. You’ll be instrumental in preparing documentation for worldwide regulatory registrations and ensuring continued compliance with ISO 13485, UK Medical Device Regulations, and EU MDR.

Key responsibilities include:

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Maintaining and reviewing technical documentation to meet regulatory requirements

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Updating Declarations of Conformity and relevant databases (e.g., MHRA, EUDAMED)

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Liaising with cross-functional teams including Quality and New Product Development

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Supporting device registration processes and ensuring correct documentation storage

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Covering additional department duties when required

This is an exciting opportunity for someone who thrives in a regulated environment and is passionate about ensuring medical products meet global compliance standards.

Skills & Experience:
To be successful as a Regulatory Affairs Officer, you will ideally have:

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Working knowledge of ISO 13485, UK MDR 2002, and Regulation (EU) 2017/745 (MDR)

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Excellent attention to detail and documentation skills

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Strong verbal and written communication

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Proficiency in Microsoft Office applications

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Ability to manage workload and prioritise effectively

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A background in working with confidential or sensitive data

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Commitment to continued professional development

While experience in global medical device regulations is desirable, candidates with a strong willingness to learn and grow into the Regulatory Affairs Officer role are encouraged to apply.

Why Should You Apply?

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Be part of a growing and innovative company with a global reach

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Gain hands-on experience in international regulatory affairs

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Work in a friendly, supportive environment that promotes growth

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Ideal step for someone looking to solidify their career as a Regulatory Affairs Officer

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Competitive pay with long-term career prospects

If you’re ready to make a difference in the industry and build a rewarding career as a Regulatory Affairs Officer, we’d love to hear from you