Director of Regulatory Compliance & Validation Strategy

Join Lumafield, a cutting-edge technology company focused on revolutionizing the way engineers make decisions. As the Director of Regulatory Compliance & Validation Strategy, you will own the Quality Management System across all of Lumafield's operations, ensuring adherence to international quality standards. You will lead compliance initiatives, work directly with enterprise customers, manage audits, and drive continuous improvement. This is an exciting opportunity to make a significant impact in a fast-growing startup.

• Assurer la conformité réglementaire et la validation des systèmes de Lumafield, en particulier dans les secteurs médical, automobile, aéronautique et de la défense.
• Diriger la mise en œuvre et le maintien d'un système de gestion de la qualité unifié qui couvre l'ensemble des opérations de Lumafield, en veillant à l'évolutivité et au respect des normes de qualité internationales.
• Agir en tant que conseiller stratégique pour les équipes internes, en fournissant des conseils sur les exigences réglementaires et les meilleures pratiques en matière d'assurance qualité.
• 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
• 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
• A Strategic Thinker: You understand how to balance the need for rigorous quality processes with the agility required in a fast-growing startup
• 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
• 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
• Collaborative: You enjoy working cross-functionally and view the Quality function as an enabler of speed and innovation
• Experience with FDA 21 CFR Part 820, EU MDR, IATF 16949, AS9100, or NADCAP
• Direct experience as a Lead Auditor (ISO 9001, ISO 13485, or ISO/IEC 17025) or ASQ CQA / CQE certification
• Prior experience standing up a calibration lab or ISO/IEC 17025 scope from scratch
• Hands-on background with industrial CT, CMM, or other dimensional metrology systems, and the GD&T workflows they support
• Experience supporting customers through their own regulatory filings (510(k), PMA) using data generated on a vendor’s equipment
• Experience at a fast-growing hardware/software company where the QMS had to scale with the business
• Experience with statistical process control, test method validation/MSA, CAPA, NCMR, PPAP, FAI