Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, EU MDR, and UK MDR.
Provide clear, structured audit documentation and evidence-based conclusions.
Contribute to consistent, high-quality audit experiences aligned with Scarlet’s audit methodology and values.
Scarlet is authorized by governments to assess and grant market access to medical AIs, enabling innovative technology to reach patients safely and quickly. They are considered the pre-eminent authority on AI medical devices, serving well-resourced and ambitious companies.
Support registrations, submissions, and lifecycle maintenance activities.
Help maintain and improve QMS processes and records to support ISO 13485 certification.
Receive, log, review, and route product complaints for investigation.
Dandy is transforming the antiquated dental industry through technology. Backed by leading venture capital firms, Dandy is building the operating system for dental offices around the world—empowering clinicians and their teams to achieve more for their practices, their people, and their patients.
Lead the development and execution of Care Access’s quality program across clinical, operational, and technology domains.
Build and maintain a risk-based, fit-for-purpose Quality Management System (QMS) that supports Care Access’s mission.
Collaborate with Operational Compliance, Product, Privacy, IT, and other functional partners to embed quality by design across systems and workflows.
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, they bring world-class research and health services directly to communities that often face barriers to care.
Leads and Coordinates and ensures compliance to CAPA, HHA and NCE systems.
Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations.
Participates in internal audits, supplier audits to ensure systems comply with requirements and are effective.
Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM) and is broadening its vision beyond diabetes to empower people to take control of their health. Thousands of ambitious, passionate people worldwide are willing to fight like warriors to earn the trust of our customers.
Oversee clinical quality assurance, develop training programs, and ensure regulatory compliance.
Design, implement, and oversee clinical quality assurance programs for in-home care delivery.
Design and implement onboarding and continuing education programs for clinical team members.
Sprinter Health is an innovative healthcare startup dedicated to providing high-quality, in-home and virtual care across the country. They employ a multidisciplinary team of clinicians, technologists and operators backed by investors including a16z, General Catalyst, GV, and Accel.
Lead Wheel’s commitment to clinical excellence, overseeing programs such as Clinical Protocol Design.
Integrate clinical insights into our virtual care platform, ensuring scalable and safe virtual care delivery.
Define key performance metrics and implement mechanisms to drive continuous improvement across quality, safety, and clinician experience.
Wheel is evolving the traditional care ecosystem by equipping the nation's most innovative companies with a premier platform to deliver high-quality virtual care at scale. They offer proven strategies and cutting-edge technologies to foster consumer engagement, build brand loyalty, and maximize return on investment.
Ensure we consistently ship high-quality, usable product experiences
Review design work and provide clear, thoughtful feedback
Partner with product managers to ensure strong context, requirements, and research
Tremendous is a platform for sending bulk payouts to people in over 230 countries and regions. They are a fully remote, profitable company with over 20,000 companies using the platform and are growing without outside investors.
Be the RA representative on core functional teams for advertising and promotion and global software regulatory classification.
Work closely with SW development, engineering, architect, quality and cybersecurity teams.
Represent RA in the assessment of global cybersecurity and data privacy initiatives.
Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). They have broadened their vision beyond diabetes to empower people to take control of their health with personalized, actionable insights. Dexcom has thousands of ambitious, passionate people worldwide.
Drive execution of NPI strategy to develop scalable, high-yield processes.
Optimize inspection strategies through technology, automation, and supplier certification.
Coach and develop a team of quality engineers to meet performance metrics.
Stryker is a leading medical technology company committed to improving healthcare. They offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine. They are proud to be named one of the World’s Best Workplaces!
Develop and report key quality metrics across all clinical programs and trials.
Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations.
Drive inspection readiness at local and global levels.
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.
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.
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.