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.
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.
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.
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.
Ensure the quality, reliability, and performance of advanced medical software solutions.
Design, implement, and execute comprehensive test plans, combining both automated and manual testing approaches to identify and resolve software issues.
Validate that features meet business requirements and user needs while maintaining high standards of software quality.
This position is posted by Jobgether on behalf of a partner company We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly.
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 standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program.
Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and clinical trials.
Plan, lead, conduct, document, report, and follow-up of clinical quality audits according to regional compliance regulations, guidance, contracts, and quality agreements.
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.