Sr. Software Regulatory Affairs Specialist

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.

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.