Director of Quality Systems, SaMD | Hybrid

Elucid; Boston (MA); Hybrid; USD 175,000 - 225,000; Full time

Benefits offered by this job

Hybrid work model

Office in Boston

Job summary

Elucid, a Boston-based medical technology company leveraging AI for cardiovascular care, is seeking a Director of Quality Systems to own the quality strategy and QMS. You will lead a ground-up quality team, shaping how a novel SaMD product is developed, cleared globally, and evolved with ongoing lifecycle management, collaborating closely with R&D, Regulatory, Clinical and Product teams.

The ideal candidate brings 7+ years in Quality Management or Regulatory Affairs in medical devices, 2–5+

Qualifications

• 7+ years of Quality Management or Regulatory Affairs experience in the medical device industry and 2–5+ years of people management experience. SaaS product experience preferred.
• Advanced degree in Life Sciences, Engineering or a related discipline.
• Hands-on experience guiding software development lifecycle activities in an agile environment with monthly releases, working with Product and Engineering to maintain compliance.
• Demonstrated expertise in SaMD regulatory frameworks, including FDA Class II and EU MDR Class IIa/IIb; familiarity with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366.
• Experience leading quality management system (QMS) activities including audits, CAPA, risk management and post-market compliance such as vigilance reporting and change assessments.
• Strong collaboration and communication skills, translating regulatory requirements into actionable guidance for cross-functional execution.

Responsibilities

• Own quality strategy execution and our quality management system (QMS).
• Lead a team of quality professionals from the ground up.
• Shape how a novel, ML-powered SaMD product is developed, cleared globally, and evolves over its lifecycle.
• Partner with R&D, Regulatory Affairs, Clinical and Product to drive quality processes across teams.
• Translate complex regulatory requirements into actionable guidance and drive cross-functional execution.

Skills

Quality leadership

Regulatory compliance

Cross-functional collaboration

Communication skills

Project management

Education

Advanced degree in Life Sciences, Engineering or related discipline

Tools

QMS Audits

CAPA

Job description

Elucid, a Boston-based medical technology company leveraging AI for cardiovascular care, is seeking a Director of Quality Systems to own the quality strategy and QMS. You will lead a ground-up quality team, shaping how a novel SaMD product is developed, cleared globally, and evolved with ongoing lifecycle management, collaborating closely with R&D, Regulatory, Clinical and Product teams.

The ideal candidate brings 7+ years in Quality Management or Regulatory Affairs in medical devices, 2–5+