PECA Labs is a Pittsburgh based medical device manufacturer within the cardiovascular space with both vascular graft and valve products. This is a team oriented position that will see the hire working within quality systems but in conjunction with manufacturing and the rest of the team.

Position will require

• Maintain and grow company's ISO 13485 and FDA-Compliant Quality System
• Work in conjunction with other quality systems employees
• Experience with both paper and digital QC systems preferred
• Experience with internal and external audits necessary
• 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 regulations