Job Information
Zimmer Biomet Senior Regulatory Affairs Specialist in Galway, Ireland
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
Responsible for ensuring that regulatory submissions are appropriately developed for approval and clearance of new orthopedic devices, evaluating changes to orthopedic devices and the manufacturing processes. Regulatory submissions can include, but are not limited to EU class III, IIb, IIa and Ir Technical Documentation, US FDA Class III PMA and Class II (510k) submissions as well as supporting global submissions
How You'll Create Impact
Develop Regulatory strategy for NPI projects, changes to devices and changes to manufacturing processes.
Provide support, training and guidance to junior RA team members.
Review as applicable documents created by junior RA team members.
Develop documents to submit to Notified Bodies and FDA including:
Technical Documentation MDR (EU) 2017/745).
Change notifications.
Premarket notifications (510(k)).
Premarket Applications (PMA) – original, supplements or annual reports.
Develop internal documentation when formal FDA submissions are not required (LTF or Memo-to-File).
Supports, supervises, approves, and participates (as necessary) in the development of package inserts (IFUs), evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status.
Review and approve Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP) and other applicable Clinical documentation such as SSCP.
Provide input into Post Market Surveillance Update Reports (PSUR) and review and approve PSURs.
Review and approve Engineering Change Requests (ECRs).
Development and updating of internal operating procedures.
Submit documents to support International registration submission requests.
Participate in other RA activities as needed.
What Makes You Stand Out
Strong Knowledge of EU and USA regulations.
Knowledge of international medical device regulations.
Strong attention to detail.
Strong computer skills, including word processing, spreadsheet and data programs.
Good oral and written communication skills.
Your Background
Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
A minimum of five years of experience in orthopaedic or medical device industry preferred
A minimum of 5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
Regulatory Affairs Certification (US or EU) preferred
A combination of education and experience may be considered
Travel Expectations
- Up to 15%
EOE/M/F/Vet/Disability