Director of Regulatory Compliance & Validation Strategy

TL;DR

Director of Regulatory Compliance & Validation Strategy: Own the Quality Management System (QMS) and lead regulatory compliance and validation strategy across hardware, software, cloud services, metrology, and scan lab operations with an accent on ISO 9001, ISO 13485, ISO/IEC 17025, and 21 CFR Part 820 for medical device customers. Focus on scaling a unified QMS, preparing for audits and inspections, and guiding product and engineering to deliver fully validated solutions in regulated environments.

Company

Quality-focused medical device technology company building scanners used for regulated, high-stakes decisions.

What you will do

• Own and maintain a unified QMS covering the full scope of operations, ensuring scalability and adherence to international quality standards.
• Lead compliance initiatives for ISO 9001 and ISO/IEC 17025, and prepare for additional certifications as the business expands.
• Partner with enterprise customers to support validation with technical documentation and assurance for their QMS and submissions.
• Advise Product and Engineering to deliver fully validated solutions for customers in regulated industries.
• Serve as the primary point of contact for customer audits, regulatory inspections, and internal quality assessments.
• Drive continuous improvement using data-driven insights to refine processes and mitigate risks.

Requirements

• Location: Cambridge, MA
• 10+ years of experience managing quality systems in highly technical or regulated environments, especially medical devices.
• Hands-on compliance expertise with ISO 9001, ISO 17025, and 21 CFR Part 11, including Computer Systems Validation (CSV) and IQ/OQ/PQ.
• Ability to adapt SOPs to meet customer requirements across Medical Device (primary), and also Automotive, Aerospace, and Defense sectors; strong understanding of ISO 13485 and 21 CFR Part 820.
• Ability to translate complex quality and regulatory requirements into actionable guidance for engineers and present validations clearly to enterprise customers.
• Cross-functional collaboration experience, with the Quality function viewed as an enabler of speed and innovation.

Culture & Benefits

• Quality function positioned as a strategic enabler for engineering speed and innovation.
• Cross-functional partnership across sales, customer success, product, and engineering.
• Data-driven continuous improvement culture focused on risk mitigation.
• Direct customer-facing involvement supporting validation and audits.

Hiring process

• Interviews focused on regulatory/compliance depth, QMS ownership experience, and customer audit/validation leadership.
• Discussion of how experience maps to ISO 9001/ISO 13485/ISO/IEC 17025 and 21 CFR Part 820 execution in a fast-growing environment.

Location: Cambridge, MA

Salary: $160,000 - $190,000 per year