Regulatory Affairs Specialist

Job Title
Regulatory Affairs Specialist

Job Description

Job title:
Regulatory Affairs Specialist

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 business unit Programs and assists with regulatory matters such as labeling, marketing, technical documents, and 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
• Guide 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 business unit product lines based on completion of localization and licensing.
  
  

• Relevant academic degree, B.Sc. in engineering and/or life science is preferable
• Knowledge of the relevant global regulations for successful preparation and submission of 510(k), PMA, TF and international registrations worldwide
• Ability to communicate effectively with cross-functional teams
• Excellent English skills (written and oral)
• M.Sc. - an advantage
• Certified regulatory affairs professional- an advantage
  
  

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