Sr. Software Regulatory Affairs Specialist

📋 Description

• Develop U.S. and international regulatory submission packages for new medical devices and changes
• Define regulatory pathways for software development and product updates, identifying documentation
• Assess software, firmware, and hardware changes to determine applicable filing requirements and
• Review software lifecycle records, verification and validation results, risk management
• Integrate technical testing, product risk, and cybersecurity documentation into complete and
• Coordinate responses to regulatory agency questions by gathering technical input and preparing

🎯 Requirements

• Direct regulatory affairs experience with Class II and Class III medical devices, including
• Experience with standalone medical software, embedded software, and medical devices that integrate
• Ability to assess software lifecycle documentation, verification and validation results
• 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

🎁 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.