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Job Post Details

Regulatory Affairs Sr Specialist - job post

Zimmer Biomet Polska Sp.
3.5 na 5 gwiazdek
zdalnie
Pełny etat
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Opis stanowiska

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Wymiar pracy

  • Pełny etat

Lokalizacja

zdalnie

Pełny opis stanowiska

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 recognized.


What You Can Expect


As a Regulatory Affairs Sr Specialist, you will be responsible for ensuring that regulatory submissions are appropriately developed for approval and clearance of our products. These Regulatory submissions can include, but are not limited to class III Technical Documentation, preparation of technical Documentation for class I, IIa, IIb (EU). You will ensure regulatory interface throughout the product realization process and during the entire product life cycle including post-market surveillance.

How You Create Impact


  • Sit on design review teams and provide interactive feedback and assist in the development of supporting documentation
  • Develop Regulatory strategy for NPI projects
  • Assist in the development and implementation of post-market surveillance
  • Develop documents to submit to Notified Bodies and FDA
    • Technical Documentation and Technical files (as per MDD 93/42/EEC or MDR (EU) 2017/745)
    • Change notifications
    • Premarket notifications (510(k))
    • Premarket Applications (PMA)
    • Investigational Device Exemption (IDE)
  • Develop internal documentation
  • Supports, supervises, approves, and participates 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
  • Develop progress reports and other misc. reports

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


You hold a Bachelor's or higher degree in clinical / science field, with a proven track record of at least 5+ years of experience in medical devices regulatory affairs, preferably in orthopaedics.


EOE/M/F/Vet/Disability

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