Summary of 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.
Essential Duties and ResponsibilitiesQuality Systems & Compliance- 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.
Supplier Quality- 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.
Complaint Handling & Post-Market Surveillance- Oversee complaint investigations, trending, adverse event reporting, and post-market surveillance activities.
- Identify quality signals and ensure appropriate escalation and risk management actions.
Risk Management & Product Development- 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.
Regulatory Affairs- 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.
Audits & Operational Quality- Support regulatory inspections, product audits, and ISO 13485 certification audits.
- Drive operational quality improvements, nonconformance investigations, process validation, inspections, calibration, and training activities.
Qualifications Expected for Position- 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.
Preferred Qualifications- ASQ certification and/or Lead Auditor certification.
- Experience supporting regulatory inspections and certification audits.
The base salary range for this position is $140,000 - $150,000. In addition to a base salary, this position is eligible for a performance bonus and benefits (subject to eligibility requirements) listed here: Teladoc Health Benefits 2026. Total compensation is based on several factors including, but not limited to, type of position, location, education level, work experience, and certifications. This information is applicable for all full-time positions.
We follow a Flexible Vacation Policy, intended for rest, relaxation, and personal time. All time off must be approved by your manager prior to use. You will also receive 80 hours of Paid Sick, Safe, and Caregiver Leave annually. This applies to full-time positions only. If you are applying for a part-time role, your recruiter can provide additional details.
As part of our hiring process, we verify identity and credentials, conduct interviews (live or video), and screen for fraud or misrepresentation. Applicants who falsify information will be disqualified.
Teladoc Health will not sponsor or transfer employment work visas for this position. Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future.
