Sr. Software Regulatory Affairs Specialist
Benefits
4w PTO
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About the Role:
- 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.
Benefits:
- 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.