Manager, Post-Market Quality

Element Science•Redwood City, CA

10h

About The Position

Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery. We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience—designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
5+ years in Quality Assurance or Regulatory Affairs within a regulated industry (Medical Device, Biotech, or Pharma) with 2+ years of managing direct reports.
Familiarity with CMS DMEPOS Quality Standards.
Demonstrated experience linking complaint trends to CAPA initiation and risk management file updates.
Deep expertise in FDA 21 CFR Part 803 (MDR), Part 820, and ISO 13485/14971 including hands on experience with authoring MDRs.
Working knowledge of EU MDR Vigilance reporting obligations.
Experience managing complaints in a validated electronic management system or quality management system (e.g. Salesforce, Master Control, ETQ or equivalent)
Proficiency in statistical trending, complaint metrics, and data visualization tools, including excel.
Ability to present complex post-market data clearly to management and cross functional stake holders.

Nice To Haves

Preferred experience with Class III PMA devices and/or AI/ML Software as Medical Device (SaMD)

Responsibilities

Own the intake process for all incoming product feedback, distinguishing between general inquiries and events meeting the formal complaint definition per internal procedures.
Ensure each confirmed complaint is properly opened, coded and assigned within the complaint management system per internal procedures.
Monitor queue status and throughput; ensure no reportable events or high severity complaints are delayed at intake. Ensure reportable complaints are reported within the mandated regulatory requirements.
Manage the end-to-end investigation process, ensuring technical teams identify failure modes and that documentation meets audit-ready standards. Maintain investigation completeness cycle time within SLA targets.
Lead the assessment of adverse events for FDA reportability per internal procedures. Ensure Medical Device Reports (MDRs) are submitted accurately and within statutory timelines.
Oversee EU MDR Vigilance reporting as applicable to Element Science regulatory scope and authorized representative obligations.
Ensure each complaint is closed with complete investigation findings, root cause determination, risk assessment and appropriate regulatory assessment. Maintain closure cycle time within SLA targets.
Evaluate whether complaint trends necessitate an escalation to the Corrective and Preventive Action (CAPA) system or other risk-based containment measures.
Responsible for publishing weekly, monthly and quarterly complaint metrics for internal stakeholders and Management Review.
Perform Post-Market Surveillance (PMS) analysis to identify emerging risks or "signals" that were not previously identified in the Risk Management File. Escalate findings promptly.
Present findings to Executive Leadership and Quality Management Reviews, providing actionable insights that influence Engineering, Clinical and Manufacturing priorities.
Ensure the complaint management system remains in alignment with CMS DMEPOS Quality Standards as implemented through Element Science CHAP accreditation, specifically regarding the timely resolution of grievances and the documentation of beneficiary interactions.