8 дней назад
Senior Medical Device Quality & Regulatory Engineer
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Medical Device Quality & Regulatory Engineer (Medtech/ISO 13485): Owning quality and regulatory processes across the lifecycle of an FDA-approved Class III neuromodulation device, from design and development through manufacturing and post-market activities with an accent on design controls, technical documentation, supplier quality, and regulatory compliance. Focus on maintaining the QMS, supporting FDA and EU MDR submissions, preparing for audits, and driving cross-functional quality improvements.
Location: Hybrid in Skåne, Sweden, or London, UK; office attendance is required a few times per week.
Company
develops clinically proven, non-drug mental health treatments combining neuroscience, hardware, and software.
What you will do
- Lead and maintain design controls, including design history files, verification and validation, risk management, and device change control.
- Own technical documentation, technical files, DHFs, and DMRs across the product lifecycle.
- Drive supplier qualification, audits, manufacturing quality control, and process improvements with contract manufacturers.
- Collaborate with R&D, product, regulatory, supply chain, and operations teams on design and process changes.
- Support and improve the ISO 13485-certified quality management system.
- Support FDA and EU MDR submissions, regulatory updates, audits, and inspection readiness.
Requirements
- Strong technical background in medical-device software or hardware/product engineering.
- Hands-on experience with active medical-device design, development, and manufacturing.
- Strong knowledge of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820).
- Experience with supplier and manufacturing quality control, technical files, DHFs, and DMRs.
- Experience implementing and maintaining ISO 13485 quality management systems and working with FDA regulations and EU MDR.
- Experience with FDA inspections or Notified Body audits, plus strong technical project management skills.
Nice to have
- Experience with FDA PMA Class III devices and PMA supplements.
- Experience with combination hardware/software medical devices or neurotechnology.
- Experience with eQMS, quality-system automation, or AI tools.
- Experience working with Asia-based contract manufacturers.
Culture & Benefits
- Work on a clinically proven treatment for major depressive disorder.
- Own significant parts of the quality and regulatory infrastructure for a US Class III device.
- Operate with high autonomy in a scaling environment where new processes and systems are still being built.
- Collaborate across science, engineering, manufacturing, quality, and regulatory functions.
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