Evaluates complaints to determine reportability in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting, etc.
Performs and/or coordinates complaint investigations and gathering of additional information.
Ensures issues are being addressed and escalated in a timely manner.
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information.
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.
Implement action plans for approval of submissions.
Improve internal processes and foster relationships.
They are a company using AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. They identify the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Co-ordinate and compile regulatory submissions and agency correspondence for assigned projects
Implement action plans to achieve timely approval of submissions ensuring compliance
Participate in and support project teams to achieve regulatory goals
Jobgether is acting as a job platform partnering with other companies. They utilize an AI-powered matching process to ensure fair application reviews, identifying top candidates for client companies, though final hiring decisions are managed by the client's internal team.
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.
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.
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.
Ensure consumer contact follow-ups are conducted using appropriate questions as required
Review adverse events to determine if they are potentially serious and escalate accordingly
Track and trend adverse events on a monthly and quarterly basis
Nutrafol is a growing company that creates clinically tested products for hair growth and provide support for people at every step of their hair journey. They embrace individuality and differences and empower themselves and others with their passion for wellness and innovation.
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.
Achieve mandatory Medical Device Regulation certification to maintain European market access.
Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence.
Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry.
Docplanner Group aims to help people live longer, healthier lives by connecting patients with doctors across 13 countries. With 3,000+ employees, they provide marketplaces, SaaS, and AI tools to simplify daily tasks for healthcare professionals.
Prepare, track, and maintain all correspondence and regulatory documentation required by the IRB, FDA and other institutional and federal oversight committees.
Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
Maintain study regulatory binders and files and perform internal audit and quality assurance checks on regulatory documents.
Fred Hutchinson Cancer Center is a non-profit organization focused on adult cancer treatment and research. They are based in Seattle and have a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines.
Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review applications to Regulatory Authorities
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees
Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.
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 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.
Maintain document control policies, procedures, and systems in accordance with GXP regulations.
Ensure proper classification, indexing, version control, and archiving of GXP-related documents, including current and historical records.
Work in partnership with various departments to ensure GXP document accuracy and relevance.
Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. They are a fast-paced company committed to building an exceptional company culture, founded on their C.O.R.E. values: Caring, Original, Resilient and Egoless.
Track and monitor clinical staff training completion, including study-specific and mandatory compliance training.
Support DOA matrix setup and maintenance by confirming training completion and role assignments.
Upload and maintain essential staff training records, certifications, and staff documents in the eISF and associated systems.
Care Access aims to improve the future of health for everyone by bringing research and health services to communities. They operate with hundreds of research locations and mobile clinics across the globe and are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to medical breakthroughs.