Lumafield

1 month ago

Director of Regulatory Compliance & Validation Strategy

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 6 hours agoStatus: Live

Job Summary

Lead Lumafield's quality management and validation strategy across hardware, software, and services. Drive ISO 9001, ISO 13485, ISO 17025, and 21 CFR Part 11 programs, coordinate audits, and partner with engineering, product, and customer-facing teams to ensure compliant, validated solutions for regulated industries.

Location: Cambridge

Workplace: Onsite

Employment Type: Full time

Job Function: Legal, Risk & Compliance

Key Responsibilities

•Own the Quality Management System across Lumafield, covering design and development planning, hardware manufacturing, software, cloud services, metrology and measurement, field service, and customer-facing applications.
•Lead Lumafield’s compliance program against ISO 9001 and ISO/IEC 17025, and prepare for additional certifications as the business expands.
•Work directly with enterprise customers to demonstrate system robustness, providing technical documentation and validation assurance.
•Advise on and provide leadership to Product and Engineering to deliver fully validated solutions in regulated industries.
•Serve as the primary contact for customer audits, regulatory inspections, and internal quality assessments.

Pay and Benefits

Salary: USD 160,000 - 190,000 annually

Key Requirements

•10+ years of experience managing quality systems in highly technical or regulated environments, particularly in medical devices.
•Hands-on experience implementing ISO 9001, ISO 17025, and 21 CFR Part 11, CSV, IQ/OQ/PQ.
•Ability to adapt SOPs to satisfy customer requirements in Medical Device, Automotive, Aerospace, and Defense sectors; understands ISO 13485 & 21 CFR Part 820.
•Strategic thinker; balance rigorous quality processes with startup agility.
•Strong communication skills to translate quality requirements into actionable guidance for engineers and enterprise customers.

Experience:10+ yearsMedical devicesRegulated environmentsQuality systemsComplianceValidation

Skills:CommunicationStrategic thinkingCollaborationLeadershipProblem-solving

Certifications:ASQ CQACQE

Languages:English

Tech Stack:ISO 9001ISO 13485ISO 1702521 CFR Part 11CSVIQ/OQ/PQ

Company Brief

Lumafield

Provides industrial 3D X-ray (CT) scanning hardware and software with AI-powered analytics for nondestructive inspection, quality assurance, and reverse engineering across manufacturing and electronics industries.

Industry: Industrial Machinery

Company Size: Medium (51 to 250 employees)

Growth: Growth Stage Startup

Headquarters: Cambridge, United States

Website LinkedIn

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Lumafield

1 month ago

Director of Regulatory Compliance & Validation Strategy

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 6 hours agoStatus: Live

Job Summary

Location: Cambridge

Workplace: Onsite

Employment Type: Full time

Job Function: Legal, Risk & Compliance

Key Responsibilities

•Own the Quality Management System across Lumafield, covering design and development planning, hardware manufacturing, software, cloud services, metrology and measurement, field service, and customer-facing applications.
•Lead Lumafield’s compliance program against ISO 9001 and ISO/IEC 17025, and prepare for additional certifications as the business expands.
•Work directly with enterprise customers to demonstrate system robustness, providing technical documentation and validation assurance.
•Advise on and provide leadership to Product and Engineering to deliver fully validated solutions in regulated industries.
•Serve as the primary contact for customer audits, regulatory inspections, and internal quality assessments.

Pay and Benefits

Salary: USD 160,000 - 190,000 annually

Key Requirements

•10+ years of experience managing quality systems in highly technical or regulated environments, particularly in medical devices.
•Hands-on experience implementing ISO 9001, ISO 17025, and 21 CFR Part 11, CSV, IQ/OQ/PQ.
•Ability to adapt SOPs to satisfy customer requirements in Medical Device, Automotive, Aerospace, and Defense sectors; understands ISO 13485 & 21 CFR Part 820.
•Strategic thinker; balance rigorous quality processes with startup agility.
•Strong communication skills to translate quality requirements into actionable guidance for engineers and enterprise customers.

Experience:10+ yearsMedical devicesRegulated environmentsQuality systemsComplianceValidation

Skills:CommunicationStrategic thinkingCollaborationLeadershipProblem-solving

Certifications:ASQ CQACQE

Languages:English

Tech Stack:ISO 9001ISO 13485ISO 1702521 CFR Part 11CSVIQ/OQ/PQ

Company Brief

Lumafield

Industry: Industrial Machinery

Company Size: Medium (51 to 250 employees)

Growth: Growth Stage Startup

Headquarters: Cambridge, United States

Website LinkedIn