Sr. Software Regulatory Affairs Specialist

Accountabilities

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.