Job Details: Senior Regulatory Affairs Associate
We are looking to recruit a Senior Regulatory Affairs Associate to join the Advanced Woundcare Business.
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. Established in 1991, the Group has more than 1,500 employees.
What will this role involve?
* Maintain current Design History Files in line with Quality Management System requirements.
* Generation and submission of high-quality regulatory compliant documentation for all classes of products 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.
* Leading product risk management for all phases of the product life cycle.
* Act as a core team member for new product developments and major extensions to existing product lines.
* Supporting the development of new product Regulatory Strategy documents.
* Responsible for regulatory review and approval of key compliance records e.g., design control documentation, labeling, marketing literature.
* Act as regulatory technical documentation 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 regulatory affairs activities.
* Continuous improvement and development of the generation and maintenance processes of regulatory documentation.
* Promote the Care, Fair, Dare company values and 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 regulatory role.
* Working knowledge of regulatory requirements and design and development process is desirable.
* Experience of Risk Management within the Medical Device industry.
* Ideally has experience in key market approval requirements within Europe and the USA.
* Excellent communication skills both written and verbally with employees, customers, and Regulatory Authorities.
* Good organizational skills, including efficiency, responsiveness, and collaboration in a team environment.
* Ability to work under pressure to meet process/project timeframes and regulatory requirements.
* Strong analytical skills.
* The ability to influence and challenge others constructively.
* Competent IT skills in preparing regulatory documentation, files, and logs.
#J-18808-Ljbffr