Senior Regulatory Affairs Specialist

2 months ago

Shannon, Ireland Zimmer Biomet Full time
Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet

What You Can Expect

As a Senior Regulatory Affairs Specialist you will be responsible for the development and execution of regulatory strategies activities to support the tasks assigned to the Global Knee Manufacturing Regulatory Affairs team.

You will provide advice on regulatory requirements to support manufacturing changes, cost saving initiatives, supplier change notifications and manufacturing transfers across the Zimmer Biomet manufacturing network. You will prepare submissions and negotiate their approval with relevant regulatory authorities. You will also assist with the regulatory license maintenance including annual reports, renewals, design/manufacturing change notification, QMS audits, and maintain manufacturing site registrations.

You will follow Zimmer Biomet corporate policies for maintaining approval of medical device products as part of the Global Knee Manufacturing Regulatory Affairs team.

How You'll Create Impact

  • 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
  • Apply 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


What Makes You Stand Out

Professional experience:
  • Minimum of five years' experience in medical device regulatory affairs
  • Experience with US Class III medical devices (PMA) preferred
  • Strong computer skills


Special expertise:
  • Strong knowledge of EU and US medical device regulations
    • Submissions types to the U.S. FDA and EU Notified Bodies
    • Experience with in assessing medical device changes
  • Ability to stay abreast of regulations pertinent to medical devices
  • Ability to identify and assess business risks for a given regulatory strategy


Your Background

Education:
  • Bachelor's Degree (4-year university degree) life sciences, technical (engineering), quality or related field required with advanced degree preferred
  • Education in Medical Device Regulatory Affairs is a plus
  • A combination of education and experience may be considered


Personal skills requirements:
  • Demonstrated technical writing and communication skills
  • Strong attention to details
  • Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
  • Ability to function well as a member of the team and build relationships between regulatory affairs and other areas of the organization


EOE/M/F/Vet/Disability

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