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United States
Remote only
Not Available
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Software Regulatory Affairs Specialist based in the United States.
This remote opportunity is ideal for a regulatory affairs professional with strong expertise in medical device software and FDA submissions. You will guide product teams through the regulatory pathway from software development to successful submission, helping identify evidence gaps before they delay product releases. The role covers Class II and Class III medical devices, including standalone software and products integrating software with hardware and mechanical components. You will work closely with engineering, quality, and product teams to connect technical documentation, risk management, testing, and cybersecurity requirements. Your work will help ensure submissions are complete, defensible, and aligned with applicable regulatory expectations. You will also support ongoing compliance as products evolve and regulations change.
As a key regulatory partner to product development and quality teams, you will translate regulatory requirements into practical guidance and ensure that software-related submissions are supported by clear, comprehensive evidence.
Develop U.S. and international regulatory submission packages for new medical devices and changes to previously approved products.
Define regulatory pathways for software development and product updates, identifying documentation and evidence gaps early in the development process.
Assess software, firmware, and hardware changes to determine applicable filing requirements and supporting documentation.
Review software lifecycle records, verification and validation results, risk management documentation, and cybersecurity evidence to support regulatory submissions.
Integrate technical testing, product risk, and cybersecurity documentation into complete and defensible submission packages.
Coordinate responses to regulatory agency questions by gathering technical input and preparing clear, focused responses.
Maintain the regulatory compliance of approved products as functionality, technical documentation, and regulatory expectations evolve.
Collaborate with engineering, quality, and product teams to incorporate regulatory requirements into development decisions, documentation strategies, and release plans.
Requirements
The ideal candidate combines hands-on medical device regulatory affairs experience with the technical knowledge needed to assess software-based products and independently manage regulatory submissions.
Direct regulatory affairs experience with Class II and Class III medical devices, including preparing FDA regulatory submissions.
Experience with standalone medical software, embedded software, and medical devices that integrate software with mechanical and electronic components.
Ability to assess software lifecycle documentation, verification and validation results, cybersecurity records, and product risk assessments.
Bachelor's degree in Engineering, Life Sciences, or a related field.
Familiarity with medical device manufacturing processes and quality requirements.
Proven ability to independently manage regulatory submissions and coordinate the technical information required from cross-functional teams.
Must reside in the U.S. Eastern Time Zone or be able to do so by the first day of employment.
Must be legally authorized to work in the United States without requiring employer-sponsored visa authorization now or in the future.
Availability for occasional business travel.
Regulatory Affairs Certification (RAC) is considered an advantage.
Benefits
Annual base salary of $125,000–$140,000, plus a 10% bonus.
Health, dental, and vision insurance coverage starting on day one.
401(k) retirement plan with employer matching after 90 days.
20 days of paid time off.
Paid holidays.
Additional wellness perks.
Remote work opportunity within the United States, subject to the Eastern Time Zone requirement.