Regulatory Affairs Associate

Advanced Medical Solutions; Plymouth; On-site; GBP 80,000 - 100,000; Full time

Job description

Regulatory Affairs Associate, Plymouth

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

• Support new product developments and creation of their submissions in Europe, USA and other global markets in compliance with regulatory requirements.
• Maintenance of regulatory approvals inclusive of associated technical regulatory documentation in accordance with The Medical Devices Regulations 2002, Medical Device Regulation [EU] 2017/745, CFR Part 820 and other global markets.
• 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.
• Perform post-market and vigilance activities in support of globally marketed devices.

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 pre-market 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.
• Responsible for regulatory review and approval of key compliance records e.g. design control documentation, labelling, marketing literature, change controls.
• 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.
• Act as regulatory technical documentation Subject Matter Expert for the preparation, participation and facilitating in responses to audits by customers, FDA, Notified Bodies and other global health authorities.
• 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.
• Perform post market surveillance activities to support 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.
• Preparation and approval of Incident Reporting and FSCA/Recall reporting to meet regulatory requirements worldwide.
• Promote the Care, Fair, Dare company values in the workplace.
• Promote the Health and Safety policies in the workplace.

What we're looking for?

• Science based degree or equivalent plus relevant experience of working in the medical device arena, preferably in a regulatory role.
• Working knowledge 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.