Quality and Regulatory Affairs Director Job at PECA Labs, Pittsburgh, PA

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  • PECA Labs
  • Pittsburgh, PA

Job Description

PECA Labs is a Pittsburgh based medical device manufacturer within the cardiovascular space with both vascular graft and valve products.

Position will require

  • Maintain and grow company's ISO 13485 and FDA-Compliant Quality System
  • Oversee and manage small quality and regulatory team
  • Develop strategies for regulatory approval and introduction of new products to market
  • Manage the process from development of regulatory strategies through to approval
  • Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approvals
  • Ensure that all regulatory-related policies and procedures are current and in accordance with applicable regulations and standards
  • Provide regulatory guidance and support to project teams, including regulatory filing strategies, testing and standards requirements
  • Establish appropriate risk analysis activities, which include the use of risk analysis tools
  • Provide updates on regulatory requirement changes, which affect individual product specifications or quality systems
  • Establish solutions to regulatory problems by utilizing novel approaches when required
  • Foster collaborative, efficient and effective working relations with regulatory authorities such as the FDA
  • Understand and implement export/import regulation

 

 

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