Remote Senior Software Regulatory Affairs Expert (FDA)

Partner Company; United States; Remote; USD 125,000 - 140,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401(k) Matching

PTO 20 days

Paid Holidays

Wellness Perks

Remote Work

Job summary

Partner Company is seeking a Remote Sr. Software Regulatory Affairs Specialist to lead regulatory work on software used in Class II/III medical devices for FDA submissions. This role demands rigorous documentation, risk assessment, and cross-functional coordination.

You'll prepare U.S. and international submission packages, ensure cybersecurity evidence, and collaborate with engineering, quality, and product teams to build defensible FDA filings. Competitive salary and benefits offered.

Qualifications

• Experience in regulatory submissions for software-enabled medical devices.
• Knowledge of FDA processes and device classifications (Class II/III).

Responsibilities

• Develop U.S. and international submission packages.
• Assess software lifecycle, risk, and cybersecurity evidence.
• Coordinate agency responses with cross-functional teams.

Skills

Regulatory Affairs

FDA Submissions

Software Regulatory

Job description

Partner Company is seeking a Remote Sr. Software Regulatory Affairs Specialist to lead regulatory work on software used in Class II/III medical devices for FDA submissions. This role demands rigorous documentation, risk assessment, and cross-functional coordination.

You'll prepare U.S. and international submission packages, ensure cybersecurity evidence, and collaborate with engineering, quality, and product teams to build defensible FDA filings. Competitive salary and benefits offered.