Director of Regulatory Compliance & Validation Strategy

Director of Regulatory Compliance & Validation Strategy Lumafield - 1.0 Cambridge, MA Job Details Full-time $160,000 - $190,000 a year 2 hours ago Qualifications FDA submissions Regulatory inspections Growing experience Measurement-based inspection Customer communication Performance improvement leadership Laboratory equipment performance testing and validation Team leadership Standard Operating Procedures (SOPs) implementation Technical documentation Quality control statistical data analysis Preventive action implementation Laboratory instrument validation Statistical Process Control Internal compliance auditing Providing information to customers Corrective and preventive actions (CAPA) ISO certification audits Laboratory equipment calibration Quality control audit First article inspection Dimensional measurements Collaboration with product development teams Production validation processes Laboratory regulatory affairs Certified Quality Auditor CMM experience within medical devices industry Quality assurance standard operating procedures Compliance documentation Auditing experience within manufacturing industry Full Job Description 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. What you'll do: Own the

QMS:

Design, implement, and maintain a unified QMS that covers the full scope of Lumafield's operations, ensuring scalability and adherence to international quality standards.

Lead Compliance Initiatives:

Lead Lumafield's compliance program against

ISO 9001

(general QMS) and

ISO/IEC 17025

(metrology and calibration), and prepare the company for additional certifications as the business expands.

Customer Validation:

Work directly with enterprise customers to demonstrate the robustness of Lumafield's systems, providing technical documentation and assurance for their validation processes. Deliver approach for a validated solution : Advise on and provide leadership to Product and Engineering for Lumafield to provide fully validated solutions to our customers in regulated industries

Manage External & Internal Audits:

Serve as the primary point of contact for customer audits, regulatory body inspections, and internal quality assessments. Act as a

Strategic Advisor:

Partner with engineering, product, customer success, and sales teams to provide guidance on regulatory requirements and quality assurance best practices. This includes directly working with customers who need to validate Lumafield's systems inside their own QMS and submissions.

Drive Continuous Improvement:

Cultivate a culture of continuous improvement across the organization, using data-driven insights to refine processes and mitigate risks.

About you:

An Experienced Quality Professional:

10+ years of experience with a proven track record of managing quality systems in highly technical or regulated environments, particularly in medical devices

Compliance Expert:

You possess deep, hands-on experience navigating and implementing

ISO 9001, ISO

17025, and 21 CFR Part 11, Computer Systems Validation (CSV), and

IQ/OQ/PQ

Understands the

Customer:

Able to adapt Lumafield SOPs to satisfy customer requirements in Medical Device, Automotive, Aerospace, and Defense sectors. Understands

ISO 13485 & 21 CFR

Part 820.

A Strategic Thinker:

You understand how to balance the need for rigorous quality processes with the agility required in a fast-growing startup.

A Skilled Communicator:

You can translate complex quality requirements into actionable guidance for engineers and present system validations with clarity and authority to enterprise customers.

Collaborative:

You enjoy working cross-functionally and view the Quality function as an enabler of speed and innovation Bonus points: Direct experience as a Lead Auditor (ISO 9001, ISO 13485, or

ISO/IEC 17025

) or

ASQ CQA / CQE

certification. Experience with

FDA 21 CFR

Part 820, EU

MDR, IATF

16949, AS9100, or NADCAP. Hands-on background with industrial CT, CMM, or other dimensional metrology systems, and the GD&T workflows they support. Prior experience standing up a calibration lab or

ISO/IEC 17025

scope from scratch. Experience supporting customers through their own regulatory filings (510(k), PMA) using data generated on a vendor's equipment. Experience with statistical process control, test method validation/MSA, CAPA, NCMR, PPAP, FAI. Experience at a fast-growing hardware/software company where the QMS had to scale with the business The base salary range listed here represents the anticipated low and high end of the salary range for this position. Actual salaries may vary and may be above or below the range based on various factors including but not limited to work location, experience, and performance. All full time employees receive an equity grant. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.