Regulatory Affairs Assistant

Advanced Medical Solutions; Winsford; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading company in tissue-healing technology is seeking a Regulatory Affairs Specialist to support new product developments and ensure compliance with regulatory requirements in Europe and the USA. The role involves generating high-quality documentation, maintaining regulatory certifications, and supporting audits. Ideal candidates have a science-based degree, excellent communication skills, and relevant experience in medical devices.

Qualifications

• Relevant experience of medical devices preferred.
• Proficiency in written and spoken English required.

Responsibilities

• Generate and submit regulatory compliant documentation for product approvals.
• Maintain current registrations and ensure compliance with regulations.
• Support post market surveillance activities.

Skills

Communication

Organisational Skills

Analytical Skills

IT Skills

Education

Science based degree

Tools

Microsoft Office

Job description

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

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.

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.).