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Regulatory Affairs Associate

Advanced Medical SolutionsUnited Kingdom

30+ days ago

Job type

Full-time

Job description

Vacancy Name

Regulatory Affairs Associate

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

The regulatory affairs associate will play a critical role in ensure the compliance of device manufactured by the Advanced Medical Solutions Group in all global markets. The role is a key role within the business, interfacing with customers, notified bodies, in-country agents, regulatory authorities, Quality, Marketing, R&D, and Clinical on a regular basis.

Key responsibilities

What will this role involve?

Key Accountabilities

Compile and submit regulatory submissions for approval in applicable markets
Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical devices framework in the countries registered
Supporting and advising other functions within the business for information and registration requests
Coordinate the preparation, review and submit timely responses to requests for additional information from regulatory authorities on product registrations
Support customer market registration activities, within the terms of existing contractual obligations
Conduct Regulatory Change Assessments
Participate in and support audits / reviews by regulatory authorities and customers in regards to the International Registrations system including preparation, facilitation and response
Monitor relevant industry-wide International Registration activities
Continuous improvement and development of the international registrations process
Support internal customer projects including artwork changes and new territory expansions and / or launches
Promote and demonstrate Care, Fair and Dare values in the workplace
Promote health and safety policies in the workplace

What we're looking for?

Science based degree or equivalent

At least 2+ years' experience in Regulatory Affairs

Medical device experience and exposure to MDR 2017 / 745 preferred

Proficiency in written and spoken English required

Proficiency in written and spoken German required

Ideally has experience in key market approval requirements globally

Excellent communication skills both written and verbally with employees, customers, in country agents and Regulatory Authorities

Competent IT skill in preparing files

The ability to influence and challenge others in a constructive way so as to deliver improvements

The ability to manage workload and time effectively

Due to the nature of the role deadline delivery is critical, whilst meeting enforced regulatory timelines

Employment Basis

Full Time

Location Country

United Kingdom

Location City

Applications Close Date

31 Aug 2025 #J-18808-Ljbffr

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Regulatory Associate • United Kingdom