regulatory affairs Work, Jobs in leeds (with Salaries)

Senior Regulatory Affairs Associate
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- Engineering
- Bachelor's degree
- Organisational skills
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Senior Regulatory Affairs Associate

Medasil Surgical Ltd
Leeds

Quick apply

Job details

Full-time
£45,000 - £55,000 a year

Qualifications

Engineering
Quality management
Quality assurance
Bachelor's degree
Organisational skills
Communication skills

Full job description

Medasil Surgical Limited is currently recruiting for a Senior Regulatory Affairs Associate to join our Regulatory Affairs team based in Leeds. This is a full-time, onsite role supporting medical device compliance across UK and international markets.

Key Responsibilities

Ensure compliance with applicable medical device regulations, standards, and legislation
Create, update, and maintain Technical Documentation and Technical Files
Conduct periodic reviews of documentation to ensure compliance with harmonised standards
Perform regulatory gap analyses against new and updated regulations
Review design changes, engineering updates, CAPA, and nonconformances for regulatory impact
Support and maintain product registrations with Competent Authorities (e.g., MHRA, EUDAMED)
Ensure post-market surveillance requirements are met and reflected in Technical Documentation
Review product labelling, promotional materials, and claims for regulatory compliance
Support audits (internal and external) and regulatory inspections
Monitor regulatory changes and support updates to internal procedures and systems
Responsible for delivering high-quality, audit-ready technical documentation
Ensuring timely regulatory submissions and approvals
Proactively identifying regulatory risks and recommending solutions

Requirements

Minimum 5 years’ experience in Medical Device Regulatory Affairs
Degree in Science, Engineering, Regulatory Affairs, or a related discipline
Strong working knowledge of:
MDD 93/42/EEC, MDR 2017/745, and UKCA requirements
ISO 13485 Quality Management Systems
Experience in:
Technical Documentation and Technical File maintenance
Regulatory gap analysis
Applying harmonised standards and regulatory guidance
Reviewing CAPA, nonconformances, and design changes
Understanding of:
Risk management documentation
Clinical evaluation reports
Labelling requirements
Device registration systems (e.g., MHRA, EUDAMED)
Strong written and verbal communication skills
Good organisational skills and ability to manage multiple tasks

Desirable

RAC certification or advanced degree in Regulatory Affairs
Experience working within a regulated medical device environment

Benefits

Competitive salary (dependent on experience)
Career development and progression opportunities

Schedule:

Monday to Friday
Full-time, mainly onsite with occasional flexible working.

Medasil Surgical Limited is an equal‑opportunity employer. We welcome applications from all qualified individuals regardless of background and identity.

If you meet the above criteria and are looking to develop your career in Regulatory Affairs with Medasil Surgical Limited, please apply with your CV.

Job Type: Full-time

Pay: £45,000.00-£55,000.00 per year

Application question(s):

Do you have experience working with MDD 93/42/EEC and/or MDR 2017/745?
Are you familiar with UKCA regulatory requirements?
Do you have experience creating and maintaining Technical Documentation / Technical Files?
Are you able to work full-time onsite in Leeds?
Do you have at least 5 years of experience specifically in Medical Device Regulatory Affairs?

Education:

Bachelor's (required)

Work authorisation:

United Kingdom (required)

Work Location: In person

Quick apply

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