Global Regulatory Lead – Medical Devices Submissions

EPM Scientific; Pittsburgh (Allegheny County); In loco; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Audit readiness

Formazione

Bachelor's degree in Engineering or Life Sciences

Descrizione del lavoro

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.