Principal Regulatory Affairs Specialist

EPM Scientific; Pittsburgh (Allegheny County); On-site; USD 120,000 - 160,000; Full time

Job summary

EPM Scientific seeks a Principal Regulatory Affairs Specialist to drive global regulatory strategy and oversee submissions for a growing medical device portfolio. The role collaborates with cross-functional teams to ensure compliance in U.S. and international markets and to enable market access for life-changing technologies.

The ideal candidate will lead submissions, monitor regulatory changes, and support risk management and audit readiness across multiple regions.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 6+ years of Regulatory Affairs experience within medical devices.
• Experience with FDA 510(k), EU MDR, and international submissions.
• Strong understanding of ISO 13485 and global regulatory requirements.
• Clinical trial or clinical investigation experience preferred.

Responsibilities

• Lead and support U.S. and international regulatory submissions.
• Assess regulatory changes and evaluate impact on products and documentation.
• Support market expansion initiatives and new product launches.
• Serve as a regulatory resource for cross-functional teams and health authorities.
• Contribute to regulatory strategy, risk management, and audit readiness.

Skills

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Audit readiness

Education

Bachelor's degree in Engineering or Life Sciences

Job description

An innovative medical device company is seeking a Principal Regulatory Affairs Specialist to support global regulatory strategy and submissions across a growing product portfolio. This role offers the opportunity to work closely with cross-functional teams to bring life-changing technologies to market while ensuring compliance in U.S. and international markets.

Key Responsibilities:

• Lead and support U.S. and international regulatory submissions.


• Assess regulatory changes and evaluate impact on products and documentation.


• Support market expansion initiatives and new product launches.


• Serve as a regulatory resource for cross-functional teams and health authorities.


• Contribute to regulatory strategy, risk management, and audit readiness.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field.


• 6+ years of Regulatory Affairs experience within medical devices.


• Experience with FDA 510(k), EU MDR, and international submissions.


• Strong understanding of ISO 13485 and global regulatory requirements.


• Clinical trial or clinical investigation experience preferred.