What are the responsibilities and job description for the Quality and Regulatory Affairs Director position at PECA Labs?
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
