Sr. Software Regulatory Affairs Specialist (Fully Remote)

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

• Remote Sr. Software Regulatory Affairs Specialist for a US partner.
• Focus on Class II/III medical device software and FDA submissions.

Key Accountabilities:

• Develop U.S. and international submission packages.
• Assess software lifecycle, risk, and cybersecurity evidence.
• Coordinate agency responses with cross-functional teams.
• Annual base salary of $125,000-$140,000 plus 10% bonus.
• Health, dental, and vision insurance; 401(k) matching.
• 20 days PTO, paid holidays, wellness perks, and remote work.

Partner Company

A partner company in the medical device industry seeking a regulatory affairs expert for software products. The company values collaboration across engineering, quality, and product teams to ensure compliant and defensible FDA submissions.