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.