Maintain and support certifications and registrations including FDA, SOC 2, HITRUST, and ISO 27001 control environments.
Coordinate annual audits, evidence collection, and remediation tracking.
Support FDA and QMS program: Develop, maintain , and manage the Quality Management System (QMS), including document control, record management, and change control processes.
Plan and conduct internal QMS audits; support external audits, ensuring evidence is organized and audit-ready.
Support product clearances, approvals, and ongoing product compliance activities.
Administer complaint handling processes and manage product surveillance activities.
Coordinate field actions (e.g., recalls, corrections) as required , including regulatory notifications and effectiveness checks.
Coordinate training programs tied to QMS procedures and FDA-regulated activities.
Track corrective and preventive actions (CAPAs) and drive timely closure.
Track and report compliance metrics and control status.
Partner with Legal and Security on annual risk assessments, risk tracking and remediation.

7+ years of experience in Quality Assurance, Regulatory Affairs, compliance, or GRC within a healthcare or medical device environment.
Experience supporting SOC 2, HITRUST, FDA, and/or ISO environments.
Experience managing compliance within a HIPAA regulated environment is a plus.
Hands-on experience with QMS administration (e.g., document control, CAPAs, training records) in an FDA-regulated or healthcare SaaS environment preferred.
Relevant certifications helpful (e.g., CIPP, CIPM, CHPC, CISA).
Bachelor’s degree in a technical field (e.g., engineering, life sciences, computer science) or equivalent experience.
Trained ISO 13485 lead auditor certification highly desirable; willingness to obtain certification is acceptable.
Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint); experience with Confluence, JIRA, and Azure DevOps preferred.
Strong written and verbal communication skills with the ability to translate complex regulatory requirements into actionable procedures.
Ability to develop expertise across all aspects of TigerConnect’s quality management system post-hire.

Excellent Medical, Dental, and Vision insurance for you and your family plus a 401k match
Focus on your well-being through our wellness reimbursement program and company-wide wellness days (extra days off to rest and recharge)
Our flexible time off lets you work hard and play hard—on your schedule
Join a mission-driven team committed to making a real impact in the world of healthcare

Governance, Risk, and Compliance Manager

Key skills