Regulatory Affairs Lead - Surgical Robotics (Remote)

Genesis MedTech Group; United States; Remote; USD 140.000 - 200.000; Vollzeit

Benefits dieser Stelle

Annual performance bonus

Comprehensive benefits package

Flexible remote work

Zusammenfassung

Genesis MedTech Group seeks a Regulatory Affairs Lead to direct US regulatory strategy and FDA submissions for an advanced surgical medical device portfolio. You will own submission timelines, author complex filings, and lead agency interactions across cross-functional teams to drive development and commercialization.

The role includes end-to-end submission work, strategic pre-submission planning, and collaborating with global teams to align development and compliance timelines.

Qualifikationen

• Experience directing regulatory strategy for medical devices.
• Strong ability to author FDA submissions and manage timelines.
• Experience with GLP animal studies and human factors in submissions.

Aufgaben

• End-to-end submission authoring and timeline ownership.
• Act as primary FDA liaison for assigned products and meetings.
• Provide regulatory input to New Product Development and testing strategies.
• Assess design changes and determine regulatory pathways and exemptions.
• Coordinate global regulatory alignment for multiple markets.

Kenntnisse

Regulatory strategy

FDA submissions

Cross-functional leadership

Independent work

Project management

Ausbildung

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

Advanced degree in Engineering or Life Sciences

Jobbeschreibung

Genesis MedTech Group seeks a Regulatory Affairs Lead to direct US regulatory strategy and FDA submissions for an advanced surgical medical device portfolio. You will own submission timelines, author complex filings, and lead agency interactions across cross-functional teams to drive development and commercialization.

The role includes end-to-end submission work, strategic pre-submission planning, and collaborating with global teams to align development and compliance timelines.