Manager, Quality & Regulatory Compliance

About the role

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.

Responsibilities

• Quality 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.

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.

Preferred Qualifications

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

Pay

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.

Benefits

• Flexible Vacation Policy (all time off must be approved by your manager prior to use).
• 80 hours of Paid Sick, Safe, and Caregiver Leave annually (full-time positions only).
• Comprehensive benefits program centered around you and your family (eligibility requirements apply).

Schedule

This is a full-time position.