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

dkd2THN6Nk44aXZMeVU2WGpOS2hGeUFDdVE9PQ==
  • 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,

Similar Jobs

Verisk

MSA Nurse Reviewer Job at Verisk

MSA Nurse Reviewer Location Remote in Woburn, MA : We are seeking Medical Analysts with experience in preparing Medicare Set Asides and Medical Cost Projections. This includes reviewing records, preparing the narrative and an appropriate allocation for medical treatment... 

Green Meadow Waldorf School, Chestnut Ridge, NY

[Priority Listing] First Grade Class Teacher Job at Green Meadow Waldorf School, Chestnut Ridge, NY

 ...seeking a community of like-minded teachers, strong educational support for your class, supportive parents, active Board members and collaborative school leadership. We also welcome you to apply if you have relevant teaching experience and an interest in holistic education... 

Crown Equipment Corporation

Computer Science and Engineering Co-op - Fall 2026 Job at Crown Equipment Corporation

 ...Responsibilities: Under the guidance of engineers, work with general purpose or embedded...  ...related systems. Write and/or modify computer programs using Java, Angular, C/C++, C#,...  ...actuators and systems. Conduct bench-level unit testing and on-vehicle verification... 

Michaels Stores

Front End Manager Job at Michaels Stores

 ...satisfy federal, state, and local legal requirements of the job. Total Base Pay Range For This Position $16.00 - $22.20 At The Michaels Companies Inc., our purpose is to fuel the joy of creativity and celebration. As the leading destination for creating and... 

The Forum Group PNW

Plant Controller Job at The Forum Group PNW

 ...check, drug screen (THC not allowed) Position Overview A dynamic and growing Eugene-based manufacturing facility is seeking a Plant...  ...ERP integrity and participate in system upgrades (MS Dynamics/Nav) Confidently communicate concerns, flag discrepancies, and...