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• Support software validation and verification efforts to ensure compliance with FDA regulations and industry standards.
• Own the quality approval process for software components, including documentation review and final release approvals.
• Partner with the software engineering team to implement and maintain a robust software quality management system.

Sequel, headquartered in Manchester, New Hampshire, is developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel provides equal employment opportunities and believes that when you thrive, they thrive.

• Develop, manage, and execute global clinical studies.
• Ensure timely and budget-compliant trial activities in accordance with quality standards.
• Lead the selection and oversight of clinical trial sites.

This position is posted by Jobgether on behalf of a partner company.

• Effectively manage and resolve customer complaints, adhering to service level agreements and Complaints policy.
• Monitor and respond to customer reviews on platforms such as Trustpilot and social media.
• Proactively investigate customer issues using internal tools and processes.

Finom is a European tech startup headquartered in Amsterdam, and we’re on a journey towards revolutionizing the financial landscape for entrepreneurs worldwide.

• Ensure the quality and regulatory compliance of AI-powered SaMD products.
• Collaborate with cross-functional teams, including software development, regulatory affairs, and quality assurance.
• Maintain and review audit-ready evidence for software/AI development.

Sword Health is an AI health company that provides care programs for multiple conditions, from musculoskeletal, to women’s health, to mental health.

• Oversee the drug substance, drug product, reference standard, and packaging/labeling/serialization contract service providers for clinical-phase and commercial production activities.
• Review and approve key strategic product / process documents (i.e. specifications, batch records, tech transfer/validation protocols, etc.).
• Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business and are exemplified by each and every one of their team members.

• Provide first-line remote technical support for Growth Direct™ system robotic, software, imaging, and microbial related issues.
• Manage customer complaints per SLAs, Escalation Processes, and with Technical Service Engineer coordination as needed.
• Case management within the Customer Relation Database, inputting pertinent information that includes date stamps, symptoms, investigation details and the resolution.

Rapid Micro Biosystems creates innovative products for fast and accurate detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. They are headquartered in Lexington, Massachusetts with R&D and manufacturing operations in Lowell, Massachusetts and field offices in Germany, Switzerland, and Singapore.

• Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities.
• Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings.
• Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies.

GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. They have built a multi-disciplinary organization of scientists, engineers, and physicians and are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

Document and communicate audit findings to management and recommend corrective actions to improve compliance. Provide staff education on privacy standards, compliance policies, and regulatory requirements. Review, investigate, and respond to facility inspections and/or deficiencies issued by regulatory agencies.

SimonMed Imaging is the fastest growing outpatient radiology practice in the Nation and is committed to excellence and improving patient care.

Manage clinical trials from inception to Clinical Study Report completion to drive meaningful change for patients and healthcare providers. Author and implement operational plans for efficient study enrollment and monitoring activities. Participate in audits and regulatory inspections as needed.

This position is posted by Jobgether on behalf of a partner company.

Resolve concerns with empathy, efficiency, and professionalism. Instrumental in safeguarding reputation and enhancing service standards. Help shape improvements across operations, ensuring expectations are exceeded.

PortmanDentex is a leading dental group where your skills and ambitions make a real difference; they support over 370 practices across the UK and Ireland.

• Provide ongoing support to providers to help them maintain high-quality care delivery and professional growth.
• Monitor, track, and respond to clinical adverse events.
• Work with Customer Support, Product, Provider Success, Clinical Quality, and Care Coordination teams to execute end-to-end clinical roadmaps and SOPs.

At SonderMind, we believe everyone deserves one personalized, connected, and effective mental health destination to take care of their mental health and well-being.

• Reviews and approves marketing materials against work papers.
• Establishes and maintains strong relationships with Partners through regular communication.
• Conducts periodic reviews of Partners compliance to guidelines and rules.

Pathward is a financial empowerment company that works with innovators to increase financial availability, choice, and opportunity for all.

The Manager, Quality Assurance & Regulatory will support global quality systems, product integrity, and regulatory compliance. Heavily focused on quality assurance, including product testing, technical packaging, supplier quality management, and continuous improvement initiatives. Partner closely with Product Development, Operations, Packaging, Creative, and Customer Experience to ensure products meet Starface’s high standards.

Starface World is reinventing the way we care for acne-prone skin as the first complexion brand to combine efficacy and optimism.

• Communicating and interacting with consumers and businesses on consumer-related complaints.
• Analyzing, documenting, researching, and resolving consumer complaints in accordance with the laws, rules, and regulations enforced by DCWP.
• Maintaining Agency database and providing reports as needed.

The NYC Department of Consumer and Worker Protection (DCWP) protects and enhances the daily economic lives of New Yorkers to create thriving communities.

• Ensure compliance with standard protocol and regulatory obligations in clinical site monitoring.
• Complete on-site and remote monitoring activities, including source document verification.
• Write and submit reports of investigational site findings and update tracking systems.

At Freenome, they are dedicated to changing the entire landscape of cancer.

Ensures the quality of printed products from initial design to the final customer product. Involves hands-on inspection, data analysis, and collaboration with a network of PSPs. Maintains high standards and improves key metrics.

Minted empowers a thriving community of independent artists to sell and scale their work by nurturing self-expression, cultivating community, and bringing the best in visual art to a global audience.

Respond to customer questions and requests via email. Triage tickets and perform escalations to appropriate teams. Develop and maintain a deep understanding of our product offerings.

Prompt is revolutionizing healthcare by delivering highly automated and modern software to rehab therapy businesses, the teams within, and the patients they serve.

• Remote-first QA of clinical text and structured EHR data.
• Localized to Chicago.
• Requires careful judgment, consistent annotation quality, and attention to detail in complex datasets.

Alignerr is a recruiting company. They're looking for a Clinical Data QA Reviewer.

The FS QA Learner will support the FS QA team and ensuring compliance across our operations. You'll have the opportunity to work with a diverse range of suppliers and gain practical experience in document review and approval. The ideal candidate is highly detail-oriented and eager to learn the ins and outs of quality systems for a growing brand.

Chomps is the fastest-growing snack brand in the U.S. and they’re reimagining snacking with meat snacks made using high-quality proteins, no sugar, and real ingredients.

• Provides regulatory guidance throughout the clinical development life cycle.
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.