Regulatory Affairs Specialist – Medical Devices

Position: Regulatory Affairs Specialist – Medical Devices

Location: California

Employment Type: Contract

At Intellectt, we believe in hiring the best talent and providing them with opportunities to thrive. If you’re a detail-oriented, compliance-focused, and proactive professional, we want to hear from you!

What You'll Do:

• Prepare and submit global regulatory filings including 510(k) s, Technical Files, and other international submissions.
• Ensure compliance with FDA, EU MDR, ISO 13485, and other applicable regulatory standards.
• Collaborate cross-functionally with R&D, Quality, and Clinical teams to support product development and change control.
• Review and approve product labelling, marketing materials, and IFUs for regulatory compliance.
• Support regulatory inspections and audits by preparing and presenting necessary documentation.

What We're Looking For:

• Regulatory Submission Expertise (510(k), CE Mark, international registrations)
• Strong Knowledge of Global Medical Device Regulations (FDA, EU MDR, ISO 13485)
• Excellent Communication & Cross-Functional Collaboration Skills

Seniority level: Associate

Job function: Manufacturing, Engineering, and Management

Industries: Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing