Direct message the job poster from Advanced Medical Solutions
Head of Global Recruitment at Advanced Medical Solutions
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, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll, and Peters Surgical. AMS's products, manufactured in multiple countries, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces. 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.
What will this role involve?
* 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 changes and major extensions to existing product lines, ensuring all RA activities are included in the project plan.
* Support the development of Regulatory Strategy documents.
* Responsible for regulatory review and approval of key compliance records e.g. design control documentation, labelling, marketing literature, change controls.
* 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 proactive 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.
* 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 skills in preparing regulatory documentation, files and logs.
Seniority level
Associate
Employment type
Full-time
Job function
Science
Industries
Pharmaceutical Manufacturing
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