Overview
Vacancy Name: Regulatory Affairs Assistant
About 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. We're much more than that. With over 700 employees across the globe, we pride ourselves on creating an engaging and challenging place of work, developing individuals to the best of their abilities, and providing the right environment to foster innovation, growth and meaningful work. We are 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 value and encourage diversity across our workforce, meaning that no one will be discriminated against because of gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.
Job Details
* Submit and maintain global regulatory approvals on behalf of AMS Group to meet the requirements of the business plan.
* To support regulatory submissions for new markets and maintaining registrations and licences in existing markets.
* To support customer audit requests, tender requests and all general requests associated with International Registrations.
Key responsibilities
* 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 device 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.
* 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.
* Promote and demonstrate Care, Fair and Dare values in the workplace.
* Promote health and safety policies in the workplace.
* The role is a key role within the business, interfacing with customers, in-country agents, regulatory authorities, Quality, Marketing, R&D, and Clinical on a regular basis.
* Implements the International Registrations system for the AMS Group.
* Due to the nature of the role the individual must be able to deliver to critical deadlines and manage workload and time effectively, whilst meeting enforced regulatory timelines.
What we're looking for
* Science based degree (or equivalent), or relevant experience of working in the medical device field, preferably in a regulatory role.
* Ideally has experience in key market approval requirements within APAC, EMEA and LATAM Regions.
* Excellent communication skills both written and verbal with employees, customers, in country agents and Regulatory Authorities.
* Competent IT skills.
* The ability to influence and challenge others in a constructive way to deliver improvements.
Employment Basis
Full Time
Location
Location Country: United Kingdom
Location City: Plymouth
Applications Close Date
14 Nov 2025
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