Principal Regulatory Specialist

Peca Labs; Pittsburgh (Allegheny County); On-site; USD 75,000 - 95,000; Full time

Job summary

Peca Labs, located in Pittsburgh, is seeking a Regulatory Manager to join its Regulatory Affairs Department. This role involves working closely with Quality, Manufacturing, and R&D teams to ensure compliance with regulatory requirements for medical devices.

The ideal candidate will have 3-5 years of experience and a relevant college degree. Key responsibilities include developing regulatory strategies, overseeing submissions, and participating in audits.

Qualifications

• 3-5 years of relevant regulatory experience.
• Strong understanding of FDA CFR, EU MDR, and ISO 13485 regulations.

Responsibilities

• Contribute to regulatory approval and market introduction strategies.
• Ensure compliance with regulatory requirements.
• Provide regulatory guidance to project teams.
• Participate in audits and inspections.

Skills

Regulatory approval strategies

Compliance with regulations

Risk management

International regulations (FDA, EU MDR)

Collaboration

Education

College degree in engineering or life sciences

Job description

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

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

• 3-5 years of relevant experience
• College degree required, engineering degree or life sciences degree preferred