Regulatory Affairs Specialist

Job Title
Regulatory Affairs Specialist

Job Description

The Regulatory Affairs Specialist provides regulatory guidance for business unit product lines. The Regulatory Affairs Specialist works directly with cross functional teams to support global product market clearances .

Your role:

• Regulatory Affairs representative for DI Programs and assists with regulatory matters such as labeling, marketing, technical documents, regulatory design change assessment required in the Development Life Cycle
• Support the cross functional teams with regulatory guidance during all design control phases of a new product, major and/or minor changes
• Directly responsible for the coordination and preparation of document packages to support global submissions and regulatory activities, including US, EU and Canada [510(k) Pre-market Notifications, PMAs, Product Reports/Supplements, GUDID (UDI), Technical Files, Declarations of Conformity, international Medical Device Licenses
• Provide guidance on global compliance, such as CE Marking and product registrations, clinical evaluations, Canada Medical Device Regulations, etc.
• Support in external audits (e.g FDA, CFDA, KFDA, PMDA, Notified Bodies) for Regulatory Affairs matters.
• Serves as local regulatory interface between the markets and the BIU site
• Serves as local regulatory interface for the global business RA team
• Maintains Product Shipment Authorization for DI product lines based on completion of localization and licensing
  
  

• Relevant academic degree
• 3-5 years of experience in a relevant regulated and technical environment
• Knowledge of the relevant global regulations for successful preparation and submission of 510(k), PMA, TF and international registrations worldwide
• Experience in supporting international registrations
• Excellent English skills (written and oral)
• Ability to communicate effectively with cross functional teams
  
  

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