Staff Regulatory Affairs Specialist (Digital Health) Job at Catalyst Life Sciences, Woburn, MA

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  • Catalyst Life Sciences
  • Woburn, MA

Job Description

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

Job Tags

Worldwide,

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