Senior Technical Specialist

Job Description

Senior Technical and Regulatory Associate, Winsford. 12 Month Fixed Term. On site.

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 race, gender, age, disability, sexual orientation, or any other protected characteristic as prohibited by law.

Responsible for creation of Medical Device regulatory submissions and leading product risk management for Wound Care products, Maintenance of Design History Files and regulatory approvals inclusive of associated technical regulatory documentation in accordance with The (UK) Medical Devices Regulations 2002, Medical Device Regulation (EU) 2017/745, CFR Part 820 and other global markets.

What will this role involve?

• Maintain current Design History Files in line with Quality Management System requirements.
• Lead the product risk management process for all phases of the product life cycle and contribute to the assessment of the benefit/risk analysis.
• Act as a core team member for major extensions to existing product lines, ensuring all technical activities are included in the project plan.
• Preparation 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.
• Responsible for review and approval of key compliance records e.g. design control documentation, labelling, marketing literature, clinical documentation, change controls.
• Act as design history documentation and risk management 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 activities.
• Continuous improvement and development of the maintenance processes of regulatory and risk management documentation.
• 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 technical or regulatory role.
• Working knowledge of design and development process.
• Working knowledge of regulatory requirements is desirable.
• Working knowledge of Risk Management within a Medical Device industry.
• 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.