The Senior Associate will play a key role in supporting regulatory and human factors engineering initiatives. Responsibilities include drafting usability engineering files, conducting use related risk analysis, post-market surveillance data analysis, designing usability studies, and drafting reports.
Provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries and collaborate closely with multiple functions within Insmed and with external CROs/CMOs. Interpret regulatory guidance and regulations from various health authorities, as well as industry and government agency best practices and trends.
The Associate Director, Regulatory Affairs Devices and Combination Products works with internal and external partners to deliver products to patients, supporting regulatory objectives for the company’s development and marketed device/combination products, including coordination and management of device global submissions. This position focuses on eye care devices and next generational eye care medicinal delivery products.
Ergomed is seeking Regulatory Affairs professionals experienced in managing global complex clinical studies. The role involves leadership and functional representation for projects, managing SSU/regulatory tasks, and ensuring compliance with standards. It requires preparing regulatory information for submissions to FDA, EMA, and national authorities, and providing expert advice to clients, plus training junior staff.
This position supports the Clinical Trial Patient Safety Organization by delivering high-quality data review, evaluating the quality of clinical trial patient safety data, and contributing to process improvement. The role involves worldwide surveillance of clinical trial patient safety data, timely assessment of reported data, and independent review of safety-related data.
This fellowship program invites applications from professionals with advanced degrees and strong backgrounds in science, health policy, and/or law, offering a perspective into regulatory science/policy, drug development, and market access. The fellow will gain knowledge of regulatory issues facing healthcare companies by researching, presenting, and publishing insights on regulatory topics.
Take a lead role in advancing medical research while guiding teams that make a meaningful difference in patients' lives. As the Associate Director of Clinical Monitoring, you will provide leadership and oversight for the clinical monitoring function, driving the implementation of strategies set by senior leadership. This role is responsible for developing and executing monitoring strategies, managing multiple clinical monitoring teams, and ensuring the highest quality standards.
You will be our in‑house ex‑reviewer who ensures each surgical dressings order is fully compliant with every CMS regulation, including regulation / policies as they are applied by MACs & UPICs. You'll translate LCDs/Articles and MAC playbooks into checklists, fix packet defects pre‑bill, and run our ADRs/appeals processes. Note that this role is an hourly, part-time engagement requiring ~10 hours per week.
The Regulatory Affairs & Quality Manager maintains and improves certifications such as ISO 13485, as well as other relevant standards and regulations. They will oversee the Quality Management System (QMS), ensuring compliance and providing guidance, support, and training to the organization. The manager reports to senior management on the status of ISO systems and certifications.
Praxis's Regulatory team is seeking a Consultant for approximately 7-8 months, specifically a Senior Regulatory Submissions Manager to oversee the operational aspects of submissions to U.S. and international Regulatory Agencies. They will manage the planning, tracking, coordinating, compiling, QC, submitting, and archiving of submissions in order to ensure the submissions are of the highest quality and delivered on-time.