Director of Quality Systems

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 atElucidand be part of delivering on our mission to prevent heart attacks and strokes!

At Elucid quality isnt a checkpoint. Its 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 youll have real latitude to shape the team and the system. As our Director of Quality Systems youll own quality strategy execution and our quality management system and lead a team of quality professionals from the ground up. Youll 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 youre 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 industryand 25 years of people management experience. Experience with SaaS product preferred.
• Advanced degree inLife Sciences Engineeringor 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 championa culture of quality.
• Demonstrated expertise in SaMD regulatory frameworks including familiarity with FDA Class II devices and EU MDR Class IIa/IIb productsand 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 managementand 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 driveeffective cross-functional execution of quality processes withR&D Clinicaland Product teams.

Work Location:

• 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.

Salary Range:

• The anticipated base salary range for this position at Elucid is $175000-$225000. 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.

At Elucid we believe the best work happens in a flexible hybrid environment. Boston-area employees are encouraged to work from the office on Mondays and Wednesdays with the option to come in additional days if they prefer. Fully remote employees outside the Boston area come in as needed.

We are an equal opportunity employer and value diversity at Elucid. We do not discriminate based on race religion color national origin gender sexual orientation age marital status veteran status or disability.

We understand that self-doubt can sometimes prevent great candidates from applying. If you believe you can make an impact at Elucid even if you dont meet every qualification we encourage you to apply!