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.