Principal Regulatory Specialist

PECA Labs is a Pittsburgh-based medical device company within the cardiovascular space that manufactures both vascular graft and valve products. The Principal Regulatory Specialist position is a team-oriented position that will be part of the Regulatory Affairs Department and will work closely in conjunction with the Quality, Manufacturing, and Research and Development teams.

This position will include the following responsibilities:

• Lead the preparation and submission of regulatory applications and ensure compliance with all regulatory requirements pertaining to product approvals
• Manage the process to identify changes to regulatory requirements and standards, and assist in the determination of impact on product or process documentation
• Drive projects to enter new markets, based on business needs
• Serve as a contact for Regulatory Agencies and Health Authorities and assist in answering regulatory inquiries
• Contribute to the development of strategies for regulatory approval and introduction of new products to the market
• 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
• Take part in risk management activities, as needed
• Demonstrate strong proficiency with international regulations and standards, including FDA CFR, EU MDR, and ISO 13485
• Understand and help implement export/import regulations
• Develop solutions to regulatory problems by utilizing novel approaches when required
• Participate in internal and external audits and inspections, while fostering a collaborative, efficient, and effective working environment with compliance authorities

Experience and educational requirements:

• 6-9 years of relevant experience
• College degree required, engineering degree or life sciences degree preferred
• Experience with US and international submissions required, experience with clinical trials and investigations preferred