Regulatory Affairs Assistant

Advanced Medical Solutions; United Kingdom; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading company in advanced wound care seeks a Regulatory Affairs Assistant to support regulatory compliance and product development. The successful candidate will generate high-quality documentation for international markets and ensure compliance with medical device regulations. This full-time role requires strong communication and organizational skills, alongside a relevant science degree. Applications are open until August 31, 2025.

Qualifications

• Relevant experience with medical devices preferred.
• Proficiency in English required.
• Awareness of regulatory requirements is desirable.

Responsibilities

• Generation and submission of regulatory documentation.
• Maintain current registrations and compliance.
• Support new product developments and regulatory strategies.

Skills

Communication

Analytical skills

Organizational skills

Education

Science based degree or equivalent

Tools

Microsoft Office

Job description

Vacancy Name
Regulatory Affairs Assistant

About AMS

Who are Advanced Medical Solutions?

When we say we're a world leading independent developer and manufacturer of innovative and technologically advanced products for the global advanced wound care, wound closure and surgical markets, we're not joking. But we're much more than that...

With over 700 employees across the globe, we pride ourselves on being able to create an engaging and challenging place of work, developing individuals to the best of their abilities, and providing the correct environment to foster innovation, growth and meaningful work.

We're highly dependent on the creativity of our employees for our future growth and success. Our motto 'Care, Fair, Dare' summarises our culture, and defines the principles of how we operate as one team to achieve success.

AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.

Job Details

Job Details
To support new Biosurgical product developments and creation of submissions in Europe, USA and other international markets in compliance with regulatory requirements. In addition will support continued compliance of already marketed devices in the Biosurgicals category.

Key responsibilities

What will this role involve?
• Generation and submission of high quality regulatory compliant documentation for all classes of product in Europe, USA and other global markets to ensure approvals are achieved in a timely manner.
• Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical devices regulations in Europe, USA and other global markets.
• Maintain Regulatory Technical Documentation.
• Act as a core team member for new product developments and major extensions to existing product lines, ensuring all RA activities are included in the project plan.
• Supporting the development of new product Regulatory Strategy documents.
• Support regulatory review and approval of key compliance records e.g. design control documentation, labelling, marketing literature, change controls, risk management.
• Assessment of and submission to regulatory authorities in Europe, USA and other global markets for changes to devices, manufacture processes and the quality management system.
• Support and participate in company quality system audits.
• Monitor relevant industry-wide regulatory affairs activities.
• Continuous improvement and development of the generation and maintenance processes of regulatory documentation.
• Support post market surveillance activities including reports on the status of such activities on a periodic basis such as vigilance reporting, customer feedback, post market clinical trends and pro-active market feedback.

What we're looking for?
• Science based degree (or equivalent), relevant experience of medical devices preferred.
• Proficiency in written and spoken English required
• Awareness of regulatory requirements is desirable.
• Ideally has experience in key market approval requirements within Europe and USA.
• Excellent communication skills both written and verbally with employees, customers, and Regulatory Authorities.
• Good organisational skills, including efficiency, responsiveness, and collaboration in a team environment.
• Ability to work under pressure to meet process/project time frames, regulatory requirements, and company requirements.
• Strong analytical skills.
• The ability to influence and challenge others in a constructive way to deliver improvements.
• Competent IT skill in preparing regulatory documentation, files, and logs including Microsoft Office (Word, Excel, Powerpoint etc.).

Employment Basis
Full Time

Location Country
United Kingdom

Location City

Applications Close Date
31 Aug 2025