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
