Senior Regulatory Strategy Lead - Medical Devices (US)

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

Benefits offered by this job

Benefits package

Job summary

Hamilton Medical seeks a Principal Regulatory Affairs professional in Reno, NV to lead US device regulatory strategy, submissions (510(k), de Novo, PMA), and post‑market oversight across our medical‑device portfolio. You will partner with cross‑functional teams to ensure compliance with 21 CFR, EU MDR, and ISO 13485, driving earliest feasible approvals while maintaining high quality standards.

Ideal candidates will have RAC or equivalent certification and experience with global submissions,

Qualifications

• Strong knowledge of FDA medical device regulations (21 CFR 801, 807, 812, 814, 820, 822, 830) and ISO standards.
• Experience with 510(k), de Novo, and PMA submissions.
• Ability to work cross‑functionally and drive regulatory strategy across regions.

Responsibilities

• Develop and execute US regulatory strategies for product development and submissions.
• Coordinate with cross‑functional teams to prepare regulatory documentation for FDA submissions.
• Maintain regulatory compliance throughout product lifecycle and post‑market activities.
• Respond to agency inquiries within set timelines.
• Provide guidance on regulatory risk and labeling/packaging compliance.

Skills

FDA regulatory knowledge

Cross-functional collaboration

Regulatory strategy

Regulatory submissions

Education

Bachelor's degree in science or engineering

Regulatory Affairs Certification (RAC) preferred

Tools

Regulatory databases

Job description

Hamilton Medical seeks a Principal Regulatory Affairs professional in Reno, NV to lead US device regulatory strategy, submissions (510(k), de Novo, PMA), and post‑market oversight across our medical‑device portfolio. You will partner with cross‑functional teams to ensure compliance with 21 CFR, EU MDR, and ISO 13485, driving earliest feasible approvals while maintaining high quality standards.

Ideal candidates will have RAC or equivalent certification and experience with global submissions,