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Manager, Clinical & Product Operations

SiPhox Health
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Burlington, MA$80k - $110kFull-timePosted 4d ago

About the role

Manager, Clinical & Product Operations at SiPhox Health, an early-career yet high-stakes role supporting HIPAA/FDA-compliant clinical operations, quality, complaints handling, and new product launches. Reports to the Director of Clinical Operations.

Responsibilities

  • keep our documentation audit-ready
  • catch errors before they reach a customer
  • keep launches on track across clinical, product, operations, and software
  • manage HIPAA compliance and complaints handling day-to-day
  • keep company assets organized and build the processes the rest of the team relies on
  • work alongside the clinical team as we build new panels, kits, and results features
  • support the Director in HIPAA/FDA compliance, maintain compliance docs, track BAAs and renewal dates, HIPAA housekeeping, training records and credentialing
  • audit review workflows for biomarker panels, reports, automated insights, and AI-generated summaries; update SOPs and control documents
  • log deviations and track CAPAs; track sample rejection/draw patterns
  • own the complaint log; triage complaints; coordinate investigations; report trends
  • coordinate clinical workstream for new panels, kit variants, and results features; manage launch checklists and regulatory review
  • build and run test cases for new reports and AI features; prepare literature summaries; fact-check health content
  • document requirements for new products (biomarkers, reference ranges, interpretation rules); maintain literature support
  • audit coaching conversations and health content versus medical advice

Qualifications

  • Bachelor's degree in a health, life science, or chemistry-related field (e.g., biology, biochemistry, chemistry, biomedical engineering, biotechnology, biomathematics, nursing, clinical laboratory science)
  • At least 1 year of professional experience after college in a health or product role
  • Comfortable reading lab results, units, reference ranges, and abnormal values or ability to learn quickly
  • Highly organized with ability to manage launch checklists across multiple teams
  • Strong documentation habits
  • Comfortable with spreadsheets, ticketing systems, and shared docs
  • Plus: hands-on experience as phlebotomist, medical assistant, lab technician, or EMT

Skills

Required:Documentation and record-keepingHIPAA and FDA regulatory knowledgeQuality systems and SOPsProject/launch managementComplaint handling and investigations
Nice to have:Clinical content and product collaboration

Benefits

  • Stock options, and meaningful equity in a company solving a health problem that matters
Last updated Oct 21, 2026. Interested? Apply on the company site.
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About SiPhox Health

Wearable and At-Home protein monitoring with silicon photonic chips

We are developing a new paradigm for consumer health tech wearables by replacing a 100lb optical instrument with an area of silicon smaller than a postage stamp.

hard-techbiometricsnanosensorshealth-techhealth-&-wellness
Company profileWebsite

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