Medical Device Regulatory Specialist II

Regulatory Specialist II

PECA Labs is a Pittsburgh-based medical device company within the cardiovascular space that manufactures both vascular graft and valve products. The Regulatory Specialist II 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 :

• Contribute to the development of strategies for regulatory approval and introduction of new products to the market
• Support the preparation and submission of regulatory 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
• Take part in risk management activities, as needed
• Provide updates on changes to regulatory requirements and standards, which affect individual product specifications or quality systems
• Demonstrate 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 :