- Caldera Medical (Westlake Village, CA)
- …licensing and compliance . * Serve as primary liaison with global regulatory authorities, including FDA , EU Notified Bodies, NMPA, and TGA, managing ... strategy, manage submissions, obtain necessary licenses and approvals, and ensure compliance with US and international regulations including FDA , EU MDR/MDD,… more
- UTMB Health (Galveston, TX)
- …procedures. + Provide internal and external communications, scientific expertise, and regulatory compliance expertise; able to interact and communicate with ... FDA GLP regulations as a reference standard. The Regulatory Scientist I / II may also function as...interpersonal skills. + Knowledge of and ability to interpret regulatory requirements and perform duties in compliance … more
- University of Rochester (Rochester, NY)
- …+ Oversees internal and external audits to ensure compliance with global regulatory standards, including FDA , EMA, and ISO guidelines. + Drives Corrective ... clinical research conducted at CHeT. Ensures clinical data quality, regulatory compliance , and integrity of research documentation...standards as set forth in 21 CFR under the FDA and other regulatory agencies, the EU… more
- Lundbeck (Deerfield, IL)
- …understanding of regulatory interdependencies such as strategy, scientific messaging, promotional compliance and FDA labeling. + Ability to lead and work in ... support investigational and marketing registration packages for the US FDA . + Partner with alliance regulatory colleagues...to influence division management at all levels to support regulatory compliance needs. + Highly proficient in… more
- Kelly Services (Bridgewater, NJ)
- …Specialist with a focus on Advertising and Promotion to support the regulatory compliance of promotional, educational, and training materials for marketed ... ** Regulatory Affairs Specialist - Advertising & Promotion** **Location:**...that all promotional activities adhere to applicable US laws, FDA regulations, and company policies, and collaborates cross-functionally to… more
- Globus Medical, Inc. (Audubon, PA)
- …needed for IDE and PMA reporting + Reviewing Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performing routine ... lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Edgewell Personal Care (Allendale, NJ)
- …within the Global R&D organization who oversees all activities related to regulatory compliance across all Edgewell's brand portfolio. Responsible for assessing, ... across the organization, as well as ongoing and future regulatory compliance planning and proof of cGMP....efficiencies. + Represent EPC before government authorities such as FDA , Health Canada, TGA and others. + Maintains understanding… more
- Envista Holdings Corporation (Brea, CA)
- …for assembling CE Technical files and final review of deliverables for MDR regulatory compliance with the goal of achieving notified body approval. This ... in designing and enhancing quality management systems to facilitate overall regulatory compliance . + Responsible for authoring department standard operating… more
- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance . + Ensures global regulatory strategies defined within ... to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. + Is a leader both in… more
- Abbott (Plymouth, MN)
- …Review calibration documentation and labeling. + Support quality assurance initiatives: Ensure compliance with regulatory requirements (eg, FDA regulations, ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, ISO-13485 other regulatory requirements, Company policies, operating… more
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