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

WkZsc3pQa0ErRWZXMEIxemhOVTViejRPVEE9PQ==
  • 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

Premier Towing Recovery Roadside LLC

Tow Truck Driver Job at Premier Towing Recovery Roadside LLC

 ...Description We suggest you enter details here. Role Description This is a full-time on-site role for a Tow Truck Driver located in Portsmouth, VA. The Tow Truck Driver will be responsible for safely operating a tow truck and providing roadside... 

Paragon Systems Inc

Industrial Security Program Manager Job at Paragon Systems Inc

 ...Are you a leader driven by excellence and a passion for security? Paragon Systems, a national leader in delivering innovative risk management and protective services, is seeking a driven Regional Industrial Security Program Manager to join our team. Location:... 

Addison Group

Direct Hire Recruiter Job at Addison Group

 ...Best of Staffing lists for multiple years and continue to enjoy many accolades in the industry! The role of the Direct Hire Recruiter is primarily responsible for prospecting both new candidates and clients for the division for which they are hired. Direct Hire Recruiters... 

St. Anthony Foundation

Operations Supervisor Job at St. Anthony Foundation

Salary Range: $70,000-$75,000 annually Workdays: Monday-Friday Work Hours: 8:00 AM 4:30 PM About St. Anthonys Founded in 1950, St. Anthony's is the most comprehensive safety net service center in San Francisco, directly providing food, clothing, medical care...

CBIZ Talent Solutions

Chief Lending Officer Job at CBIZ Talent Solutions

 ...held community bank in the greater Wichita area is seeking a Chief Lending Officer (CLO) to lead its lending operations and drive continued...  ...serving local families and businesses, this bank offers a nimble, people-first culture where leadership is approachable, decisions...