Regulatory Affairs Specialist (Medical Device Regulation)

About the Role

This position provides Regulatory Affairs support for medical devices, ensuring full compliance with U.S. FDA regulations, ISO 13485, and other applicable laws and standards.

Responsibilities

• Manage device marketing authorization, facility registration, and related submissions, including MDSAP and EU MDR compliance.
• Perform Pre-Market FDA submissions (510(k) and PMA) and provide guidance on regulatory changes.
• Prepare and review European and international regulatory documentation.
• Investigate and document customer complaints, adverse events, and coordinate field actions.
• Collaborate with cross-functional teams including Quality, R&D, Customer Service, and Sales.
• Support QMS audits, remediation activities, and import/export compliance.
• Ensure adherence to all relevant FDA, ISO, and international standards.

Requirements

• Bachelor’s degree or Regulatory Affairs Certification with 2+ or 4+ years of relevant experience in an FDA-regulated environment.
• Strong knowledge of U.S. FDA medical device regulations and international standards.
• Excellent communication, collaboration, and organizational skills.
• Proficient in computer and internet research.

Physical & Additional Requirements

• Sit and use hands extensively; stand and communicate effectively.
• Occasional lifting up to ten pounds; ability to see clearly at close range.
• May require occasional travel; compliance with COVID-19 vaccination policies may apply.