Director of Regulatory Compliance & Validation Strategy

Location: Boston, MA, United States

Salary: $180,000–$210,000 per year

Company

hirify.global develops industrial CT scanning, computer vision, web-based collaboration, and AI-driven tools to improve manufacturing inspection and product development.

What you will do

• Own and scale a unified Quality Management System across design, hardware manufacturing, software, cloud services, metrology, field service, applications engineering, and scan lab operations.
• Lead compliance initiatives for ISO 9001 and ISO/IEC 17025 while preparing for additional certifications.
• Guide Product and Engineering in delivering validated solutions for customers in regulated industries.
• Provide technical documentation and validation support to enterprise customers.
• Manage customer audits, regulatory inspections, and internal quality assessments.
• Partner with engineering, product, customer success, and sales teams to drive risk reduction and continuous improvement.

Requirements

• 10+ years of experience managing quality systems in highly technical or regulated environments, particularly medical devices.
• Hands-on experience with ISO 9001, ISO 17025, 21 CFR Part 11, Computer Systems Validation, and IQ/OQ/PQ.
• Understanding of ISO 13485 and 21 CFR Part 820, with the ability to adapt SOPs for medical-device, automotive, aerospace, and defense customers.
• Ability to translate complex quality requirements into actionable guidance and present system validations to enterprise customers.
• Experience balancing rigorous quality processes with the agility required in a fast-growing startup.

Nice to have

• Lead Auditor experience or ASQ CQA/CQE certification.
• Experience with FDA 21 CFR Part 820, EU MDR, IATF 16949, AS9100, or NADCAP.
• Experience with industrial CT, CMM, dimensional metrology, GD&T, calibration labs, or ISO/IEC 17025 scope development.
• Experience supporting 510(k) or PMA filings and working with SPC, MSA, CAPA, NCMR, PPAP, or FAI.
• Experience scaling a QMS in a fast-growing hardware and software company.

Culture & Benefits

• Competitive cash and equity compensation.
• Health and wellness stipend, 401(k), parental leave, and flexible PTO.
• Commuter benefits and company-wide events.
• Inclusive workplace focused on diverse backgrounds, perspectives, and skills.