Principal Regulatory Affairs

Hamilton Company

Principal Regulatory Affairs professional at Hamilton Medical ensuring compliance with FDA regulations and global standards for medical devices while collaborating with cross-functional teams.

Posted 5/1/2026full-timeReno • Nevada • 🇺🇸 United StatesLead💰 $200,000 per yearWebsite

About the role

Key responsibilities & impact

Develop and execute US Regulatory Strategies for product development and submissions
Collaborate with multiple stakeholders across Hamilton Medical
Maintain compliance with relevant regulations, standards, and guidelines throughout the product lifecycle
Conduct risk assessments on devices and collaborate with product development teams

Requirements

What you’ll need

Strong knowledge of FDA medical device regulations (21 CFR 801, 807, 812, 814, 820, 822, and 830)
Excellent knowledge of the applicable medical device regulations in various countries, including EU-MDR 2017/745 is an advantage
Minimum of ten years of experience in the medical device industry required with at least six years in regulatory affairs
Bachelor's degree in a relevant scientific or engineering field required (advanced degree preferred)
Regulatory Affairs Certification (RAC) or other relevant certification by a recognized authority preferred

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance
Paid vacation time
Paid sick time
Disability insurance
401k
Tuition reimbursement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategiesrisk assessmentsproduct developmentcompliancemedical device regulationsFDA regulationsEU-MDR 2017/745regulatory affairs

Soft Skills

collaborationstakeholder engagement

Certifications

Regulatory Affairs Certification (RAC)