Regulatory Affairs Associate

3 weeks ago

Plymouth, United Kingdom Advanced Medical Solutions Full time

Regulatory Affairs Assistant - International Registrations.
Onsite, Plymouth, Devon.
Who are Advanced Medical Solutions?
AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers.
AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand, RESORBA, LiquiBandFix8, LIQUIFIX, Peters Surgical, Ifabond, Vitalitec and Seal-G. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal brand as well as under white label.
Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices.
AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia.
The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel.
Established in 1991, the Group has more than 1,500 employees.
For more information, please see www.admedsol.com 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 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.
What will this role involve?
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 regarding 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 their 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 verbally 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.

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