Senior Compliance/Audit Manager

TL;DR

Senior Compliance/Audit Manager (Compliance & Internal Audit): Lead and advance hirify.global’s global internal audit program to ensure compliance with regulatory requirements and quality management standards, with an accent on MDSAP, FDA QMSR (21 CFR Part 820) and ISO 13485. Focus on risk-based audit planning, inspection readiness, CAPA effectiveness monitoring, and translating enterprise compliance risks into practical quality system improvements.

Company

hirify.global is a global healthcare technology company developing medical technologies to improve patient outcomes.

What you will do

• Lead enterprise internal audit activities aligned with MDSAP, FDA QMSR, and ISO 13485 across operating units and manufacturing sites.
• Develop and execute a risk-based audit schedule and serve as Lead Auditor for complex/high-impact compliance audits.
• Provide regulatory quality subject-matter expertise, assess quality system process maturity, and identify systemic compliance risks.
• Support inspection and external audit readiness, including mock inspections and readiness assessments, and drive sustainable remediation with site leadership.
• Review audit findings, ensure root cause analysis and corrective actions, and monitor CAPA effectiveness and compliance trends.
• Mentor internal auditors and strengthen audit methodologies, tools, and analytics capabilities.

Requirements

• Bachelor’s degree plus 7+ years of experience in quality, regulatory affairs, compliance, or related functions in the medical device or regulated healthcare industry.
• Minimum 3 years of experience conducting or managing internal or regulatory audits.
• Minimum 5 years of managerial experience.
• Demonstrated expertise in MDSAP audit model, FDA QMSR / 21 CFR Part 820 transition to ISO 13485, and ISO 13485 Quality Management Systems; Certified Lead Auditor (or equivalent).
• Experience interacting with regulatory agencies or supporting regulatory inspections.
• Location: Flexible within the U.S. (onsite minimum 4 days/week) and must be based in the U.S. or a hirify.global U.S. location.

Culture & Benefits

• Onsite work expectation: minimum 4 days per week onsite.
• Competitive U.S. salary range: $145,600–$218,400, plus eligibility for the hirify.global Incentive Plan (MIP).
• Benefits for regular employees (20+ hours/week) include health, dental, vision, HSA, healthcare FSA, life insurance, long-term disability, dependent daycare spending account, and tuition assistance.
• Additional benefits for regular employees include 401(k) with employer contribution/match, paid time off and paid holidays, employee stock purchase plan, and employee assistance program.
• U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above; roles below Principal require unrestricted U.S. work authorization at hire and throughout employment.