Quality and Regulatory Internship

Location: San Francisco / Remote Employment Type: Part-Time Internship Department: Quality and Regulatory Affairs Reports to: Senior Manager, Quality and Regulatory Compliance About Teal Health Teal Health is on a mission to provide women with the tools, access, and resources they need to make their own, informed decisions regarding their health—starting with cervical cancer screenings. We’ve created the first FDA authorized at-home cervical cancer screening. We’re replacing the in-office pap smear with a cervical cancer screening that is comfortable, convenient, and designed for women. Teal Health’s solution includes a patented Teal Wand collection device and a modern telehealth platform to make it easy for women to speak with a doctor, screen at home and understand their results. Our Values We boldly champion the future women deserve. And we do this through our values, which are to elevate women, expect exceptional, and learning, every day. The Teal team lives our values and uses them to guide our decisions when building Teal. Why We Are Hiring For This Role The Quality and Regulatory Intern will support Teal Health’s Quality and Regulatory Compliance function with structured, supervised project work related to eQMS migration, regulatory research, and regulated website content review. This role will help organize and verify quality records, support document and metadata cleanup, research applicable state-level regulatory requirements, and assist with review of external-facing website content for alignment with approved regulatory and clinical claims. This internship is intended for a student or early-career professional who is interested in medical device quality systems, regulatory affairs, digital health, women’s health, and compliant commercialization. The intern will work under QARA supervision and will not independently approve quality records, regulatory positions, claims, or controlled documents. Role Overview 1. Support eQMS Migration and Quality Record Readiness Assist with organizing, indexing, and mapping controlled documents, quality records, forms, templates, training records, and related metadata to support eQMS migration activities. Compare source documents against migration trackers to identify missing records, duplicate files, version inconsistencies, obsolete references, and metadata gaps. Support document cleanup activities, including file naming, record categorization, cross-reference checks, and preparation of migration-ready packages for QARA review. Maintain project trackers that show migration status, open issues, responsible owners, and completion progress. Escalate discrepancies to the Quality and Regulatory team for review, disposition, and documented resolution. 2. Conduct Regulatory Research on State-Level Requirements Research state-level regulatory requirements that may impact Teal Health’s telehealth, at-home sample collection, laboratory coordination, patient communication, and commercial operations. Summarize regulatory findings in a clear, source-linked format that identifies the state, topic, requirement, applicability, risk level, and recommended next step. Maintain a regulatory research tracker that supports ongoing review by Quality, Regulatory, Legal, Medical, Operations, and Product stakeholders. Assist with monitoring changes to applicable regulations, guidance documents, standards, and state requirements under Quality and Regulatory supervision. Prepare concise research summaries that distinguish confirmed requirements from items requiring legal, clinical, or regulatory interpretation. 3. Support Teal Website Review for Regulatory Compliance & Labeling consistency Review selected Teal website pages, patient-facing content, FAQs, product descriptions, and claims against approved source materials, labeling, clinical evidence, and regulatory guidance provided by the CRQ team. Identify potential claim risks, inconsistent wording, outdated content, missing disclaimers, unsupported comparative statements, or language that may require regulatory, legal, medical, or marketing review. Document website review observations in a structured tracker with page links, screenshots when appropriate, issue descriptions, proposed edits, and required reviewer functions. Assist with maintaining a claim support matrix or website review log that links external-facing statements to approved source documents. Support periodic website compliance reviews as Teal expands content, patient education materials, and state availability. 4. Assist with Quality System and Regulatory Documentation Prepare draft summaries, trackers, gap assessments, and work aids for Quality and Regulatory review and approval. Support maintenance of controlled standards, guidance documents, and regulatory reference lists, including documenting publication dates, revision status, owners, and applicability. Assist with quality system projects related to document control, training, change control, supplier quality, complaint handling, CAPA, post-market surveillance, and management review as assigned. Follow Good Documentation Practices and Teal Health procedures when handling quality records and regulated information. Maintain confidentiality of company information, patient-related information, and regulated business records. 5. Support Cross-Functional Collaboration and Continuous Improvement Work closely with Quality, Regulatory, Legal, Medical, Product, Marketing, Operations, and Customer Experience stakeholders to collect information and route questions appropriately. Create clear status updates that communicate progress, blockers, risks, and decisions needed. Identify opportunities to improve trackers, templates, folder structures, workflows, and documentation practices. Participate in project meetings, training sessions, and working sessions as requested. Ask thoughtful questions, seek feedback, and apply coaching to improve quality and regulatory judgment over time. Qualifications Currently pursuing or recently completed a degree in Regulatory Affairs, Quality Assurance, Biomedical Engineering, Biology, Public Health, Health Sciences, Life Sciences, Legal Studies, Health Policy, or a related field. Interest in medical devices, diagnostics, digital health, telehealth, women’s health, or regulated healthcare operations. Strong written communication skills with the ability to summarize complex information clearly and accurately. Strong attention to detail, organization, follow-through, and comfort working with trackers, spreadsheets, and controlled documents. Basic understanding of FDA-regulated products, quality management systems, ISO 13485, 21 CFR Part 820, labeling, advertising, promotion, or healthcare compliance preferred, but not required. Experience with Microsoft Office, Google Workspace, Adobe Acrobat, and spreadsheet-based trackers preferred. Ability to handle confidential information with discretion and professionalism. Ability to work independently on assigned tasks while knowing when to elevate questions or risks. Curiosity, humility, and willingness to learn in a regulated, fast-moving startup environment. Physical and Work Environment Requirements Ability to work at a computer for extended periods of time. Ability to participate in virtual and in-person meetings as needed. Ability to review documents, spreadsheets, and web content with close attention to detail. No routine lifting or manufacturing floor work is expected for this role unless specifically assigned and supervised. Teal Health is an equal opportunity employer. We are committed to building a diverse and inclusive team and do not discriminate on the basis of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other legally protected status. #J-18808-Ljbffr Teal Health