Ensure product complaint investigations and procedures comply with FDA QSR, ISO, and Medical Device Directives for Vigilance.
Perform FTIR analysis and program mechanical lab equipment such as Chatillon to support material identification and complaint investigations.
Provide audit support and enforce compliance with equipment maintenance, hazmat, biohazard, and disposal management protocols.
Embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. We are expanding our portfolio of solutions to serve more patients, healthcare providers, and communities worldwide.
Provide customers with onsite and remote consulting and education to implement Intuitive medical technology best practices.
Collaborate with hospital stakeholders and Intuitive ecosystem partners to launch and sustain da Vinci and Ion programs.
Ensure compliance with regulations and standards for reprocessing reusable medical devices.
Intuitive is a pioneer and market leader in robotic-assisted surgery, united behind the mission that minimally invasive care is life-enhancing care. With over 25 years of experience, the company fosters an inclusive and diverse team, investing in employees' long-term growth and well-being.
Implement Veeva Solutions, configuring Vault CRM and taking various roles on projects.
Lead client engagements including workshops, UAT, and training sessions from design to delivery.
Provide expert advisory to optimize business processes and translate requirements into scalable designs.
Veeva Systems is a mission-driven cloud pioneer helping life sciences companies accelerate therapy delivery to patients. With over $3B in revenue, it is one of the fastest-growing SaaS companies, legally bound as a public benefit corporation to balance multiple stakeholder interests.
Support the receipt, processing, documentation, and tracking of product complaints.
Review complaint information for completeness and accuracy, and maintain proper records.
Analyze complaint data to identify trends and support continuous improvement.
The company operates in the healthcare and pharmaceutical sector, focusing on product quality and complaint management. It emphasizes a compliance-driven culture, cross-functional collaboration, and continuous improvement.
Ensures supplier compliance with ISO 13485, MDSAP, and EU MDR regulations.
Conducts supplier audits as Lead Auditor and owns supplier quality processes, SCARs, and CAPAs.
Partners with cross-functional teams to improve supplier controls and supports regulatory inspections.
Intuitive Surgical is a global leader in minimally invasive care, best known for its da Vinci surgical systems. The company values quality, compliance, and innovation, with a cross-functional and engineering-driven culture.
Assess manufacturers' software lifecycle processes and technical documentation for medical device software, including SaMD and AI-enabled devices, under EU MDR, UK MDR, and relevant IEC standards.
Raise and close out technical assessment findings with manufacturers, explaining regulatory requirements clearly and constructively.
Deliver consistent, high-quality assessments that match Scarlet's methodology and values, working independently with flexible scheduling.
Scarlet is a medical technology certification company that combines clinical, technical and regulatory expertise with AI agents and software to help ambitious technology companies certify AI-enabled medical devices faster without lowering safety standards. You'll join a collaborative team building the infrastructure that makes rigorous certification repeatable at scale.
Build and foster highly engaged user communities, driving product adoption and customer value through clear communication.
Represent the product organization in customer meetings and industry events, capturing customer needs to inform product decisions.
Collaborate with field teams and product management to drive customer success and product excellence across Europe.
Veeva Systems is a mission-driven industry cloud pioneer helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year and are legally bound as a public benefit corporation to balance interests of customers, employees, society, and investors.
Lead ISO 13485 lead audits of global 3PL providers, distribution hubs, and service suppliers.
Develop and maintain global 3PL quality programs, quality agreements, and compliance frameworks.
Drive CAPA/SCAR processes, quality metrics, and serve as SME during regulatory inspections.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies such as the da Vinci surgical system. The company brings together engineers, clinicians, and innovators focused on making surgery smarter, safer, and more human.
Own and continuously improve the Quality Management System for simulation products, programs, and services.
Serve as the primary quality liaison for customers, suppliers, and subcontractors, ensuring requirements flow down and are met.
Drive risk-based audits, CAPA activities, and root-cause analysis to improve quality performance and compliance.
Aechelon Technology, a Shield AI company, produces 3D simulator content including geospecific visual/sensor databases and realistic 3D models for pilot training. The company seeks passionate people committed to real-time computer graphics and the mission of improving pilot safety.
Serve as CMC regulatory expert, developing global submission strategies and assessing regulatory risks for development and commercial programs.
Lead preparation and review of CMC submission content including CTD Module 2 and Module 3 sections, and support regulatory filings from IND to MAA.
Guide CMC lifecycle management, regulatory authority interactions, and monitor emerging regulations to inform client strategies.
Opus Regulatory is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo to biotech and pharmaceutical clients. Their team is made up of biopharmaceutical leaders and innovators focused on delivering the highest level of regulatory consulting service.
Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
Develop and maintain digital/software components of quality management systems, including AI quality management systems.
Care Access brings world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, they are reimagining how clinical research and health services reach the world.
Define and lead end-to-end quality strategy for SaMD software, AI/ML models, and connected-device products.
Own software V&V strategy, ensuring traceability and regulatory compliance across web, mobile, backend, and firmware.
Embed quality into the SDLC with shift-left practices, CI/CD gates, and automated regression testing.
Sword Health builds AI-powered healthcare care programs, using AI to heal billions and remove barriers to care. With 700,000+ members, 1,000+ enterprise clients, and $500M+ raised, Sword is a fast-paced, clinical-focused AI lab.
Prepare and maintain core medical device training courses, including MDR/IVDR/ISO13485/MDSAP.
Support peer reviews and assessments for trainee exercises to ensure conformity assessment understanding.
Schedule training sessions and track the progression and qualification status of new trainees.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for sustainability and quality. With 99,600 employees across 2,600 offices, we offer a dynamic, international culture and long-term development opportunities.
Represent the reviewer's perspective across our document intelligence platform, ensuring alerts and workflows provide genuine value.
Lead discovery and validation sessions, translating reviewer needs into workflows, user stories, and acceptance criteria.
Test completed capabilities from a reviewer's perspective to identify missing requirements and workflow gaps.
ICA, Inc. is a rapidly growing D.C.-area company founded in 2009 that helps government clients with research, data science, and strategic services. Our small company prioritizes work-life balance and a collaborative 'one team' culture.
Partner directly with customers to align business processes with Veeva Vault capabilities.
Lead requirements gathering, system configuration, and full-lifecycle implementation without coding.
Serve as a trusted advisor helping customers adopt new product releases and drive continuous improvement.
Veeva Systems is a mission-driven pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. The company is a fast-growing public benefit corporation with over $3B in revenue, focused on employee success and remote work flexibility.
Design innovative product features that help customers plan, track, and manage changes for approved and trial products.
Author high-quality design specifications within an agile methodology and prioritize feature development based on strategic initiatives and customer needs.
Interact with customers, professional services, strategy, sales, engineering, and QA teams to drive high-quality product implementation and serve as a product evangelist.
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, it surpassed $3B in revenue in the last fiscal year and became a public benefit corporation in 2021.
Own the customer relationship through implementation, launch, and adoption.
Lead implementations end-to-end, coordinating technical and non-technical teams.
Define and track success measures to drive adoption and deliver value.
Keebler Health is building the operating system for value-based care, helping risk-bearing healthcare organizations thrive by unlocking the power of their data. We are an early-stage company with a collaborative, supportive culture, offering a fast-paced environment and meaningful impact.
Serve as the Responsible Person for wholesale distribution, ensuring GDP compliance and quality oversight.
Lead and develop the quality team and manage the Quality Management System across the entity.
Provide quality oversight of contract service providers, review batch records, and prepare for regulatory inspections.
BridgeBio is a biotech company pioneering a pooled project model to accelerate early-stage research for rare diseases. The company fosters a collaborative culture with small expert teams, encouraging curiosity and experimentation.
Own e-invoicing compliance by tracking mandates, formats, and timelines across countries, turning them into clear requirements.
Deliver e-invoicing to customers by project managing delivery across ERPs and countries, coordinating Product, Solutions, and Engineering.
Partner with Customer Success to build playbooks, training, and support materials for scalable e-invoicing implementations.
Traild is a high-growth SaaS company that combines AI, automation, and payments infrastructure to power the future of B2B finance. With rapid global expansion and a world-class eNPS score of 68, Traild offers a dynamic and collaborative culture.
Lead a Professional Services team delivering Vault CRM across North America.
Drive operational excellence through hiring, performance management, and strategic initiatives.
Cultivate trusted customer relationships and collaborate across Veeva.
Veeva Systems is a mission-driven pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. It surpassed $3B in revenue as one of the fastest-growing SaaS companies and operates as a public benefit corporation with a flexible Work Anywhere culture.