- Elevance Health (Mason, OH)
- …established time frames and budgets. + Assists with compliance of corporate Quality Improvement (QI) work plans. + Supports Clinical Quality Program ... health, behavioral health, long term services and supports, and psychosocial needs._ ** Clinical Quality Program Specialist** **Location:** This position is based… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …notifications are required. + Ensure SaMD compliance with FDA guidance on Clinical Decision Support (CDS) software and other regulatory frameworks. + Work ... role involves developing and implementing practices for SaMD devices to ensure regulatory compliance , expedition of product clearances and maintain the highest… more
- BD (Becton, Dickinson and Company) (Vernon Hills, IL)
- …Provide internal guidance and education regarding customer complaint processing, MDRs, and regulatory compliance . + Files MedWatch reports after Leader reviews ... across functions for assigned Quality systems + Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements +… more
- Merck (West Point, PA)
- …data management. Required Skills and Experience: + Knowledge of manufacturing, testing, quality , and supply chain processes from late clinical development ... + Familiarity with CMC operations and technology transfer from late clinical development to commercialization (manufacturing, testing, quality , supply). +… more
- Fresenius Medical Center (Waltham, MA)
- …high- quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global ... key regulatory submissions. + Collaborate with senior leadership in medical/ clinical development, commercial, and other functional areas to align regulatory … more
- Globus Medical, Inc. (Audubon, PA)
- …labeling in terms of indications and reimbursement. + Works with Product Development, Clinical Affairs, Quality , Management and other areas of the organization ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
- UTMB Health (Galveston, TX)
- …procedures. + Provide internal and external communications, scientific expertise, and regulatory compliance expertise; able to interact and communicate with ... communication and interpersonal skills. + Knowledge of and ability to interpret regulatory requirements and perform duties in compliance with those requirements.… more
- Kelly Services (San Fernando, CA)
- …compliance records + Assess supplier documents and product formulations for international regulatory compliance + Maintain compliance database + Prepare ... Specialist III - San Fernando, CA** Kelly(R) Science & Clinical is seeking a ** Regulatory Affairs Specialist...in San Fernando, CA. If you're passionate about ensuring compliance and quality in the food and… more
- J&J Family of Companies (Santa Clara, CA)
- … agencies. + Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory ... company + Review and approve advertising and promotional materials to ensure regulatory compliance + Evaluate import/export requirements + Identify emerging… more
- Stryker (Cary, IL)
- …international), including approval pathways and compliance activities. + Provides regulatory input and technical guidance on quality , preclinical, ... inspections, panel meetings, and advisory committees. + Develops and implements regulatory SOPs and procedures; supports organizational compliance through… more