Salary: $120,000–$150,000+ (Depending on Experience)
We are seeking an experienced Regulatory Affairs Specialist to support medical device compliance, regulatory documentation, and quality system activities for Class I and Class II medical devices.
This is a highly visible, hands-on role where you'll work closely with Engineering, Quality, Manufacturing, and Operations to ensure products meet FDA, ISO 13485, and customer regulatory requirements. If you enjoy working in a fast-paced manufacturing environment and want to make a direct impact, we'd love to hear from you.
What You'll Do
Support regulatory compliance activities for medical device products
Maintain technical documentation, Design History Files (DHFs), and Device Master Records (DMRs)
Review product labeling, procedures, specifications, and quality records
Support change control, risk management, audit readiness, and regulatory submissions
Assist with FDA, ISO 13485, EU MDR, and customer compliance requirements
Partner with cross-functional teams to ensure regulatory requirements are met
What We're Looking For
Bachelor's degree in a technical or related field
8+ years of Regulatory Affairs, Quality, or Compliance experience in a medical device environment
Strong knowledge of FDA 21 CFR Part 820 and ISO 13485
Experience with Class I medical devices required
Experience with Class II devices, 510(k) submissions, EU MDR, or ISO 14971 is highly preferred
Strong communication, documentation, and organizational skills
Interview Process
Teams Interview
Onsite Panel Interview and Facility Tour
Please Note: This is an on-site position and is not eligible for remote or hybrid work.
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