Senior Medical Software Regulatory Affairs Lead (Remote US)

Jobgether; Oregon; Hybrid; USD 125,000 - 140,000; Full time

Benefits offered by this job

Health, dental, vision insurance

401(k) retirement plan

Paid time off

Paid holidays

Remote work within the United States

Job summary

Jobgether, on behalf of a partner company, seeks a Sr. Software Regulatory Affairs Specialist in the United States for regulatory submissions of medical device software to the FDA.

This remote opportunity requires strong expertise in software regulatory pathways and collaboration with engineering and quality teams. You will develop submission packages, assess software changes for filing requirements, and ensure complete, defendable regulatory documentation.

Qualifications

• Direct regulatory affairs experience with Class II and Class III medical devices.
• Experience preparing FDA regulatory submissions for software as a medical device.
• Ability to review software lifecycle, verification/validation, and cybersecurity documentation.
• Familiarity with medical device manufacturing processes and quality requirements.

Responsibilities

• 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.
• 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.

Skills

Regulatory affairs experience

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Jobgether, on behalf of a partner company, seeks a Sr. Software Regulatory Affairs Specialist in the United States for regulatory submissions of medical device software to the FDA.

This remote opportunity requires strong expertise in software regulatory pathways and collaboration with engineering and quality teams. You will develop submission packages, assess software changes for filing requirements, and ensure complete, defendable regulatory documentation.