Senior Regulatory Affairs Lead - Medical Devices

Hamilton Medical, Inc.; Reno (NV); On-site; USD 180,000 - 220,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Job summary

Hamilton Medical, Inc. seeks a Principal Regulatory Affairs professional to shape regulatory strategy for a broad range of medical devices. The role focuses on US submissions (510(k), de Novo, PMA), regulatory compliance, and cross-functional collaboration to ensure safe, effective products.

The candidate will lead regulatory filings, coordinate with FDA and other authorities, and guide teams on ISO risk management and MDR requirements, with opportunities for growth.

Qualifications

• Strong knowledge of FDA medical device regulations (21 CFR 801, 807, 812, 814, 820, 822, 830).
• Experience with 510(k), de Novo, and PMA submissions.
• Regulatory affairs experience in medical devices.

Responsibilities

• Develop US regulatory strategies for product development and submissions.
• Coordinate 510(k)/de Novo/PMA filings and ensure documentation aligns with 21 CFR parts 800-1299 and EU MDR.
• Maintain compliance across product lifecycle and support post-market surveillance.
• Prepare responses to FDA questions within timelines.
• Propose regulatory strategies for IDEs and IRB agreements.
• Lead regulatory input for audits and inspections.

Skills

FDA regulations

ISO 13485/14971

Regulatory strategy

Cross-functional teamwork

Attention to detail

Regulatory intelligence

Education

Bachelor's degree in science/engineering

Job description

Hamilton Medical, Inc. seeks a Principal Regulatory Affairs professional to shape regulatory strategy for a broad range of medical devices. The role focuses on US submissions (510(k), de Novo, PMA), regulatory compliance, and cross-functional collaboration to ensure safe, effective products.

The candidate will lead regulatory filings, coordinate with FDA and other authorities, and guide teams on ISO risk management and MDR requirements, with opportunities for growth.