Governance, Risk, and Compliance Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee and maintain certifications and registrations, including FDA, SOC 2, HITRUST, and ISO 27001 control frameworks.

• Organize annual audits, gather evidence, and track remediation efforts.

• Assist with the FDA and Quality Management System (QMS) program: Develop, sustain, and manage the QMS, which includes document control, record management, and change control procedures.

• Plan and execute internal QMS audits; support external audits, ensuring that evidence is well-organized and ready for review.

• Aid in product clearances, approvals, and ongoing compliance activities related to products.

• Manage complaint handling processes and oversee product surveillance operations.

• Coordinate field actions (e.g., recalls, corrections) as necessary, including regulatory notifications and effectiveness evaluations.

• Organize training programs associated with QMS procedures and FDA-regulated activities.

• Monitor corrective and preventive actions (CAPAs) and ensure timely resolution.

• Track and report on compliance metrics and control statuses.

• Collaborate with Legal and Security teams on annual risk assessments, risk tracking, and remediation efforts.

⛳️ Requirements

• A minimum of 7 years of experience in Quality Assurance, Regulatory Affairs, compliance, or Governance, Risk, and Compliance (GRC) within a healthcare or medical device setting.

• Experience in supporting SOC 2, HITRUST, FDA, and/or ISO environments.

• Experience in managing compliance within a HIPAA-regulated environment is advantageous.

• Practical experience with QMS administration (e.g., document control, CAPAs, training records) in an FDA-regulated or healthcare SaaS environment is preferred.

• Relevant certifications are beneficial (e.g., CIPP, CIPM, CHPC, CISA).

• Bachelor’s degree in a technical discipline (e.g., engineering, life sciences, computer science) or equivalent experience.

• ISO 13485 lead auditor certification is highly desirable; willingness to pursue certification is acceptable.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint); familiarity with Confluence, JIRA, and Azure DevOps is preferred.

• Excellent written and verbal communication skills, with the ability to convert complex regulatory requirements into practical procedures.

• Capability to develop expertise across all facets of TigerConnect’s quality management system after hire.

🏝️ Benefits

• Comprehensive Medical, Dental, and Vision insurance for you and your family, along with a 401k match.

• Emphasis on your well-being through our wellness reimbursement program and company-wide wellness days (additional days off to relax and recharge).

• Our flexible time-off policy allows you to balance hard work and personal time—on your own schedule.

• Join a mission-driven team dedicated to making a significant impact in the healthcare sector.