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