Job Details: Senior Regulatory Affairs Associate 12mnth FTC
Full details of the job.
Vacancy Name: Senior Regulatory Affairs Associate 12mnth FTC
About AMS
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, marketed under various brands. AMS also supplies wound care dressings through its ActivHeal brand. The Group has made several acquisitions and has a global presence with R&D innovation hubs in multiple countries. Established in 1991, the Group has more than 1,500 employees.
AMS provides equal employment opportunities for all applicants and values diversity across its workforce.
Key Responsibilities
* 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.
* Generate and submit high-quality regulatory compliant documentation for all classes of product in Europe, USA, and other global markets to ensure timely approvals.
* Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical devices regulations.
* Review and approve 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 audits by customers, FDA, Notified Bodies, and other global health authorities.
* Participate in company quality system audits.
* Monitor relevant industry-wide activities.
* Drive continuous improvement in the generation and maintenance processes of regulatory and risk management documentation.
* Promote the Care, Fair, Dare company values in the workplace.
* Promote Health and Safety policies in the workplace.
What We're Looking For?
* Science-based degree or equivalent plus relevant experience in the medical device arena, preferably in a technical or regulatory role.
* Working knowledge of design and development processes.
* Working knowledge of regulatory requirements is desirable.
* Working knowledge of Risk Management within the Medical Device industry.
* Experience in key market approval requirements within Europe and USA is ideal.
* Excellent communication skills, both written and verbal, 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 and regulatory requirements.
* Strong analytical skills.
* The ability to influence and challenge others constructively to deliver improvements.
* Competent IT skills in preparing regulatory documentation, files, and logs.
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