Compliance Officer – Medical Devices (EMS) (AR)

This role ensures full compliance with FDA regulations (QMSR / 21 CFR 820), ISO 13485, and applicable international regulatory requirements, while acting as the primary interface with auditors, customers, and regulatory bodies. The ideal candidate brings deep hands-on experience in regulated EMS environments and is comfortable operating at both strategic and tactical levels.

Quality & Regulatory Compliance

· Own and maintain the site Quality Management System (QMS) in alignment with:

o FDA QMSR (21 CFR 820 – ISO 13485:2016 aligned)

o ISO 13485 and applicable global regulations

· Monitor and implement regulatory updates (FDA, ISO, international) and translate them into actionable site requirements.

· Ensure QMS documentation is current, effective, and audit-ready.

Audits & Inspections

· Lead and host:

o FDA inspections

o ISO / registrar audits

o Customer audits (medical device OEMs)

· Own audit preparation, execution, response, and closure.

· Develop and track CAPAs to ensure root cause effectiveness and prevention of recurrence.

Risk Management & CAPA

· Ensure robust risk management practices across:

o Manufacturing processes

o Material changes

o Supplier changes

· Lead investigations for quality events, deviations, and escapes.

· Ensure CAPAs are data-driven, systemic, and aligned with regulatory expectations.

Supplier & External Compliance

· Oversee supplier qualification, audits, and ongoing monitoring.

· Ensure compliance related to:

o Outsourced processes

o Critical suppliers

o Cybersecurity considerations impacting QMS (as applicable)

Manufacturing & Operations Interface

· Partner closely with:

o Manufacturing Engineering

o Quality

o Supply Chain

o Operations