Regulatory Affairs Specialist II

About the role

The Regulatory Affairs Specialist II provides comprehensive regulatory support for medical devices in both domestic and international markets. The role works closely with cross‑functional teams to prepare and submit 510(k), Master Files, IDE, PMA, Technical Files and Design Dossiers, ensuring global marketing approvals.

Key responsibilities

• Partner with Quality, Engineering, Operations and Document Control to ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP and other applicable regulations.
• Coordinate preparation, assembly and submission of regulatory filings for product development, clinical trials, marketing authorizations and post‑market activities, including 510(k) submissions, Technical Files and international registrations.
• Conduct internal audits, support customer audits and provide regulatory guidance to project teams throughout the product lifecycle.
• Maintain organized regulatory files, databases and documentation controls in collaboration with document control specialists.

Required profile

• Bachelor’s degree in a science or engineering field (biology, chemistry, pharmacy); advanced degree preferred.
• 3‑5 years of experience in a regulated environment such as clinical research or medical device manufacturing.
• Experience working with international manufacturing locations and fluency in English and Spanish.

Required skills

• Knowledge of FDA Quality System Regulation (21 CFR Part 820) and ISO 13485.
• Familiarity with EU MDR, MDSAP and Class II/III medical device regulations.
• Hands‑on experience preparing 510(k) submissions, Technical Files, Design Dossiers and other regulatory dossiers.
• Ability to interpret and communicate regulatory requirements to internal stakeholders.