Location: Oranmore or Shannon Job Summary We are seeking a Senior Regulatory Affairs Specialist to join our team at Zimmer Biomet. In summary the job will involve the development and execution of regulatory strategies activities to support the tasks assigned to the Global Knee Manufacturing Regulatory Affairs team. The Senior Regulatory Affairs Specialist provides advice on regulatory requirements to support manufacturing changes, cost saving initiatives, supplier change notifications and manufacturing transfers across the Zimmer Biomet manufacturing network. The Senior Regulatory Affairs Specialist prepares submissions and negotiates their approval with relevant regulatory authorities. The Senior Regulatory Affairs Specialist also assists with the regulatory license maintenance including annual reports, renewals, design/manufacturing change notification, QMS audits, and maintain manufacturing site registrations. The candidate will follow Zimmer Biomet corporate policies for maintaining approval of medical device products as part of the Global Knee Manufacturing Regulatory Affairs team. The candidate will have a high level understanding in areas that include: EU and US medical device regulations Submissions types to the U.S. FDA and EU Notified Bodies Experience with in assessing medical device changes General Functions: Maintain Zimmer Biomet regulatory approvals and ensure compliance with all applicable regulations Responsible for coordinating the planning, preparation, assembly, and review of regulatory submissions to the FDA, Notified Bodies and other worldwide government agencies as required to ensure timely approval for market release. Able to write regulatory justifications to support submission filing decisions Prepare FDA regulatory submissions including US Class III 30 Day Notices and US Class II 510(k)submissions as applicable for product changes/Transfers. Prepare Change Notifications and submissions to EU Notified Bodies for Zimmer Biomet products Prepare dossiers for registration of products in countries outside the U.S and EU Support value improvement engineering teams on possible regulatory impact of proposed changes during project initiation and implementation Applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization. Work with international Zimmer Biomet regulatory staff and technical experts to resolve potential regulatory issues and questions from regulatory agencies Provide support, training and guidance to junior RA team members. Establish and maintain regulatory information systems both electronically and hard copy. Expected Areas of Competence Demonstrated technical writing and communication skills. Strong attention to details, and ability to multitask. Understanding of relevant EU MDR and US regulations, and ability to stay abreast of regulations pertinent to medical devices. Ability to function well as a member of the team and build relationships between regulatory affairs and other areas of the organization. Strong computer skills. Able to identify and assess business risks for a given regulatory strategy. Education/ Experience Requirements Bachelors Degree (4-year university degree) life sciences, technical (engineering), quality or related field required with advanced degree preferred. Experience with Class III medical devices (PMA) preferred. Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines. Minimum of five years experience in medical device or pharmaceutical regulatory affairs is required Education and experience in Medical Device Regulatory Affairs a plus but not required. A combination of education and experience may be considered. Skills: Medical Device Regulatory Benefits: Medical Aid / Health Care bonus Pension
