Senior Regulatory Program Manager

Job Summary

Collaborating cross-functionally, the full-time Senior Regulatory Program Manager will lead pre-market submissions and registrations for medical device software, ensuring compliance with evolving regulations while working remotely from within the US.

Key responsibilities

• Organize and support pre-market submissions and current registrations across global markets
• Build and maintain integrated program plans, tracking key departmental priorities and submission timelines
• Standardize Medical Device Regulatory Affairs processes and perform quality checks on submission packages

Required qualifications

• BA/BS or advanced degree with at least 8 years of relevant experience in regulatory affairs
• Experience working within a quality management system, preferably with ISO 9001 or ISO 13485
• Strong expertise in PowerPoint, Excel, and project management tools
• Proven ability to manage cross-functional initiatives in a dynamic environment
• Familiarity with regulatory filing requirements and electronic submission systems