Manager, Quality & Regulatory Compliance

Teladoc Health•Goleta, CA

1d•$140,000 - $150,000

About The Position

The Manager, Quality & Regulatory Compliance oversees the Quality Management System (QMS) and ensures compliance with applicable quality and regulatory requirements. This role partners cross-functionally to support ISO 13485 compliance, audits, supplier quality, CAPA, risk management, product development, post-market activities, and regulatory submissions.

Requirements

Bachelor's degree in Engineering, Quality, Regulatory Affairs, Life Sciences, or related field.
7+ years of experience in medical devices, healthcare technology, or another regulated industry.
Experience with ISO 13485 or similar quality management systems.
Knowledge of CAPA, audits, supplier quality, complaint handling, risk management, and design controls.
Strong project management, organizational, and communication skills.

Nice To Haves

ASQ certification and/or Lead Auditor certification.
Experience supporting regulatory inspections and certification audits.

Responsibilities

Maintain and improve the QMS in compliance with ISO 13485 and applicable regulations.
Manage document control, SOPs, training, quality records, and management reviews.
Coordinate internal, external, and certification audits.
Monitor quality metrics and drive continuous improvement initiatives.
Lead CAPA processes, root cause investigations, and corrective actions.
Manage supplier qualification, audits, and Approved Supplier List activities.
Support supplier performance monitoring, investigations, and corrective actions.
Review supplier changes and assess quality and regulatory impact.
Oversee complaint investigations, trending, adverse event reporting, and post-market surveillance activities.
Identify quality signals and ensure appropriate escalation and risk management actions.
Maintain product risk management documentation throughout the product lifecycle.
Support design control, product development, verification, validation, and change management activities.
Ensure quality and regulatory requirements are integrated into development processes.
Develop regulatory strategies and support product registrations, submissions, approvals, and licenses.
Maintain technical documentation and regulatory compliance in global markets, including CE Marking activities.
Review product labeling, marketing materials, and promotional claims for compliance.
Support regulatory inspections, product audits, and ISO 13485 certification audits.
Drive operational quality improvements, nonconformance investigations, process validation, inspections, calibration, and training activities.