DIRECT HIRE - Regulatory Affairs

Job Description

Job Description

Must Have:

• Medical Device experience
• Class A ISO 1485 experience

Key Responsibilities:

• Maintain and update regulatory documentation for Class I medical devices; support Class II documentation where applicable.
• Assist with Design History Files, Device Master Records, Technical Files, and regulatory evidence packages.
• Support FDA 21 CFR Part 820 / QMSR transition activities, ISO 13485 compliance, and customer-specific regulatory requirements.
• Review and approve product labeling, IFUs, specifications, drawings, procedures, and quality records for regulatory compliance.
• Support risk management files in accordance with ISO 14971, including hazard analysis, risk controls, and traceability.
• Assist with change control assessments to determine regulatory impact.
• Support internal audits, external audits, customer audits, and certification body audits.
• Work cross-functionally with Quality, Engineering, Manufacturing, Supply Chain, and Program Management to ensure regulatory requirements are understood and implemented.
• Support EU MDR, FDA, and international regulatory documentation requests as needed.
• Assist in preparing regulatory responses, customer questionnaires, compliance letters, and technical documentation packages.
• Maintain awareness of applicable standards, regulations, and guidance documents.
• Support supplier regulatory documentation, including declarations, certificates, compliance forms, and supplier change notifications.
• Help ensure product documentation is complete, accurate, controlled, and audit-ready.