Principal Regulatory Affairs Specialist

Opportunity to join a $1.5billion global Medical Device company as part of their regulatory affairs team, leading all SaMD, Digital Health, and AI/ML regulatory activities.

Responsibilities

• Provide leadership to assigned digital health/software project teams throughout the product lifecycles to achieve worldwide clearance/approval/registration in alignment with business objectives.
• Assess regulatory pathways for marketing new and modified products containing software; Develop associated strategies and tactical plans for submissions to FDA, EU Notified Body and other agencies.
• Identify and communicate risks and mitigations associated with regulatory strategies to cross-functional partners.

Experience Required

• B.S. or B.A. degree in a technical subject area (e.g., engineering, biology, chemistry). Advanced degree preferred.
• 5 years of directly related professional regulatory experience with software products in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields