Regulatory Affairs Advisor

 

Position Title: Regulatory Affairs Advisor

 

Position Summary: The Regulatory Affairs Advisor is a mid-level technical position.

 

The Regulatory Advisor will assist with the implementation of new global processes and procedures, facility registrations outside the US, and UDI implementation. He/she will determine the key regulatory procedures, ensure compliance to current medical device standards, adopt industry best practices where possible, and implement specific processes and procedures.

 

Key Responsibilities:

  • Create, develop, and execute global regulatory procedures and quality processes.
  • Track and manage the status of each document in the document control process.
  • Clearly present obstacles and suggested solutions to the team lead.
  • Review, revise, summarize and disseminate key updates and changes for product submissions.
  • Create and execute regulatory compliance submissions and filings.
  • Provide analysis of data and files to ensure compliance with company policies and external regulations.

     

 

Qualifications Required:

  • CE-Mark experience is desired. FDA, 510(k), and PMA experiences are required.
  • Familiarity with UDI requirements for Class I, II, and III
  • 3+ years experience in regulatory and/or quality compliance fields
  • Minimum Bachelor’s degree in a scientific/technological field
  • Strong problem-solving and communication skills
  • Experience in regulatory-approval processes and requirements
  • Excellent organizational skills
  • Experience with document-management systems such as EtQ, Agile, etc.
  • High work ethic with excellent time-management skills
  • Experience in participating in cross-functional projects
  • Ability to follow assigned tasks and meet aggressive project deadlines
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