Senior Regulatory Affairs Associate

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

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