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Sr. Software Regulatory Affairs Specialist at Jobgether - ApplyBlast

Sr. Software Regulatory Affairs Specialist

Jobgether

3 days ago

Remote

Full Time

Senior

0 applicants

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About this role

The Sr. Software Regulatory Affairs Specialist serves as a key regulatory partner to product development and quality teams, translating regulatory requirements into practical guidance for medical device submissions. This role involves defining regulatory pathways, assessing software and hardware changes, and integrating technical documentation into comprehensive submission packages. The position requires close collaboration with engineering and quality teams to ensure compliance and support product releases.

Responsibilities

Develop regulatory submission packages for new and modified medical devices
Define regulatory pathways and identify documentation gaps for software products
Review software lifecycle records and cybersecurity evidence to support submissions

Skills

Qualifications

Bachelor's degree in Engineering, Life Sciences, or a related fieldRegulatory Affairs Certification (RAC)

About Jobgether

jobgether.com

Headquarters

Brussels, Belgium

Company Size

11-50 employees

Founded

2020

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Jobgether is a remote job platform and career tool designed specifically for senior professionals with 10+ years of experience. It uses AI-powered matching to surface relevant remote and flexible roles, providing match scores, CV review, LinkedIn optimization, and one-click auto-apply. The platform also offers networking guidance and career coaching to help experienced professionals improve their positioning and land the right opportunities faster.