Regulatory Manager - Medical Devices (FDA/EU MDR)

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, 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.