Job Summary

• Develop and execute the regulatory strategy for new product development, design changes, and field safety corrections, with a primary focus on Software as a Medical Device (SaMD).
• Author 510K submissions, pre-sub documents, EUMDR tech files, and contribute to international regulatory submissions.
• Monitor global regulatory landscapes and guide cross-functional teams on implementation of regulation changes.

Matching Summary

Salary

Base: $114,750 to $205,632; Bonus/Equity: annual incentive bonus, sales commission or long-term incentives may be offered; Benefits: generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement

Skills & Requirements

Key Requirements

• Minimum of 7+ years' experience in Regulatory Affairs/Strategy
• Proven expertise in SaMD, IEC 82304, IEC 81001-5-1/ISO 27001
• Authored multiple 510Ks
• Proven experience in EUMDR tech files
• Pre-Sub notifications submitted to the FDA
• Familiarity with FDA, EU MDR, Health Canada
• Bachelors’ Degree (Required)
• US work authorization

Work Rights