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Senior Regulatory Affairs Specialist - SaMD & Software

Job in Passaic, Passaic County, New Jersey, 07055, USA
Listing for: Skills Alliance
Full Time position
Listed on 2026-09-30
Job specializations:
  • Healthcare
    Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 120000 - 170000 USD Yearly USD 120000.00 170000.00 YEAR
Job Description & How to Apply Below

Skills Alliance, a commercial stage organ technology company in New Jersey, seeks a Senior Regulatory Affairs Specialist (Software) to lead regulatory efforts for Digital Health, Software, Cybersecurity, and Electromechanical projects.

You will prepare submissions for FDA and Health Canada, interact with regulators, and track regulatory changes while coordinating with Manufacturing, Quality, R&D, Clinical, and Marketing teams.

We have an opening for a Senior Regulatory Affairs Specialist
- SaMD & Software in NJ, United States within Legal, Management & Operations.

This role, Senior Regulatory Affairs Specialist
- SaMD & Software at Skills Alliance, could be your next opportunity.

Are you ready to take on the Senior Regulatory Affairs Specialist
- SaMD & Software role at Skills Alliance?

We would love to welcome a new Senior Regulatory Affairs Specialist
- SaMD & Software to our group in NJ, United States.

Position Requirements
10+ Years work experience
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