The Role
Lead execution of quality strategy and ownership of the QMS for a machine-learning SaMD. Build and manage a quality team, guide software V&V and release processes, ensure global regulatory compliance (FDA, EU MDR), run audits, CAPA, risk and post-market activities, and partner cross-functionally with R&D, Regulatory, Clinical and Product to ensure safe, compliant product lifecycle.
Summary Generated by Built In
We are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes!
At Elucid, quality isn't a checkpoint. It's core to how we bring transformative cardiovascular AI to physicians. This is a new role for us, created as we build out our quality function, so you'll have real latitude to shape the team and the system. As our Director of Quality Systems, you'll own quality strategy execution and our quality management system, and lead a team of quality professionals from the ground up. You'll shape how a novel, machine learning powered SaMD product is developed, cleared globally and evolves over its lifecycle, partnering closely with R&D, Regulatory Affairs, Clinical and Product. If you're a SaMD quality leader who thrives at the intersection of science, strategy and compliance, we would love to build together to revolutionize cardiovascular care.
The ideal candidate will have:
At Elucid, quality isn't a checkpoint. It's core to how we bring transformative cardiovascular AI to physicians. This is a new role for us, created as we build out our quality function, so you'll have real latitude to shape the team and the system. As our Director of Quality Systems, you'll own quality strategy execution and our quality management system, and lead a team of quality professionals from the ground up. You'll shape how a novel, machine learning powered SaMD product is developed, cleared globally and evolves over its lifecycle, partnering closely with R&D, Regulatory Affairs, Clinical and Product. If you're a SaMD quality leader who thrives at the intersection of science, strategy and compliance, we would love to build together to revolutionize cardiovascular care.
The ideal candidate will have:
- 7+ years of Quality Management or Regulatory Affairs experience in the medical device industry and 2–5+ years of people management experience. Experience with SaaS product preferred.
- Advanced degree in Life Sciences, Engineering or a related discipline.
- Deep hands-on experience guiding software development lifecycle activities in an agile environment with monthly releases (testing strategy, design transfer, release processes, etc.), working with Product and Engineering teams to maintain compliance and champion a culture of quality.
- Demonstrated expertise in SaMD regulatory frameworks, including familiarity with FDA Class II devices and EU MDR Class IIa/IIb products, and working knowledge of standards such as 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
- Experience leading quality management system (QMS) activities including audits, CAPA, risk management and post-market compliance requirements such as vigilance reporting and change assessments.
- Strong collaboration and communication skills, with the ability to translate complex regulatory requirements into actionable guidance and drive effective, cross-functional execution of quality processes with R&D, Clinical and Product teams.
- This is a on-site role based out of our office in Boston, MA. Our team is hybrid and has a preference for local candidates or those located in eastern time zones in the continental U.S.
- The anticipated base salary range for this position at Elucid is $175,000-$225,000. Compensation will be influenced by a wide array of factors including but not limited to internal pay equity, job-related knowledge, skills, education, relevant experience, certifications, and geography as outlined in the job description.
Skills Required
- 7+ years of Quality Management or Regulatory Affairs experience in the medical device industry
- 2-5+ years of people management experience
- Advanced degree in Life Sciences, Engineering or related discipline
- Hands-on experience guiding software development lifecycle activities (V&V, testing strategy, design transfer, release processes) with Product teams
- Demonstrated expertise in SaMD regulatory frameworks and familiarity with FDA Class II and EU MDR Class IIa/IIb
- Working knowledge of standards: 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366
- Experience leading QMS activities including audits, CAPA, risk management, vigilance reporting and change assessments
- Strong collaboration and communication skills to translate regulatory requirements into actionable guidance
- On-site work from Boston, MA (preference for local or Eastern time zone candidates)
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The Company
What We Do
Elucid is a Boston-based medical technology company using uniquely interpretable and validated AI to provide physicians with a cost-effective means to optimize treatment decisions for patients with cardiovascular disease. Advanced clinical insight from Elucid equips physicians with critical information designed to enable precision medicine. Elucid is the first FDA-Cleared and CE-marked non-invasive software to quantify atherosclerotic plaque characteristics compared to histopathology, including Lipid Rich Necrotic Core. The company has published studies for its derivation of fractional flow reserve (FFRct) based on the vasodilative capacity of the vessel wall and estimation of coding and non-coding RNA transcripts (“Virtual Transcriptomics”). This unique information informs improved treatment decisions by physicians leading to better patient outcomes, improved quality of care, and reduced healthcare costs. The Elucid software is available for commercial use in the U.S. and Europe
