Director of Regulatory Compliance & Validation Strategy

Lumafield

Cambridge, US

On-site

Who this role is best for

Aimed at senior quality professionals who bridge technical innovation with regulatory compliance in medical devices and related industries.

Best fit for

Experienced quality leaders comfortable owning end-to-end quality management across hardware and software.
— “own the Quality Management System across all of Lumafield”
Strategic advisors who can guide both internal teams and external customers on compliance.
— “act as a bridge between our cutting-edge technology and the rigorous compliance standards”
Professionals with deep expertise in medical device regulations and ISO standards.
— “primary industry focus is medical devices”

Things to consider

Role requires managing compliance across multiple domains including hardware, software, and cloud services.
— “design and development planning, hardware manufacturing, software, cloud services”
Expect to lead customer audits and support system validation efforts.
— “guide customers and support validation of our systems and lead customer audits”

How to stand out

Demonstrate experience implementing ISO 9001 and ISO 13485 in a technology-driven environment.
— “compliance with ISO 9001, ISO 13485, ISO 17025, 21 CFR Part 820”
Highlight instances where you served as a strategic advisor across multiple departments.
— “strategic advisor to our internal teams, spanning sales, customer success, product and engineering”
Showcase leadership in customer-facing quality initiatives and audit management.
— “lead customer audits”

Pace · SteadyCollaboration · HighAutonomy · HighDecision Impact · CompanyLevel · Senior

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

own Quality Management System
achieve and maintain compliance
guide internal teams

Typical background

quality leadershipregulatory compliance

Skills & requirements

Required

Quality ManagementRegulatory ComplianceValidation StrategyISO StandardsCustomer Audits

Preferred

IATF 16949As9100

Stack & domain

Regulatory ComplianceValidation StrategyQuality Management

About the role

Original posting from Lumafield via Lever

About the role:
Quality is how Lumafield earns trust — with the engineers who rely on our scanners to make million-dollar decisions, with the regulated industries we serve, and with the certification bodies who audit us.
Lumafield’s Quality Leader will own the Quality Management System across all of Lumafield: design and development planning, hardware manufacturing, software, cloud services, metrology and measurement, field service, and our customer-facing applications engineering and scan lab operations.
The Quality Leader acts as a bridge between our cutting-edge technology and the rigorous compliance standards our customers demand. This can include leading our efforts in achieving and maintaining compliance with ISO 9001, ISO 13485, ISO 17025, 21 CFR Part 820, and potentially IATF 16949 and AS9100, however the primary industry focus is medical devices.
You will act as a strategic advisor to our internal teams, spanning sales, customer success, product and engineering. You’ll also guide customers and support validation of our systems and lead customer audits.

Source: Lumafield careers (Lever)