- Abbott (Plano, TX)
- …with cross-functional partners including Systems Engineering, Clinical Engineering, Electrical Engineering, Quality , and Regulatory . This position works out of ... with applicable standards (ASTM F2182, F2052, F2213, ISO, IEC, FDA guidance). Team & Resource Management + Lead, mentor,...+ Build strong partnerships with external R&D functional teams ( Quality , Regulatory , Operations, etc.) + Represent MRI… more
- PCI Pharma Services (Rockford, IL)
- …will lead equipment, process, and cleaning validation efforts to ensure compliance with FDA , ISO 13485, and other applicable regulatory standards. This role is ... medical device production. + Collaborate with cross-functional teams, including Manufacturing, Quality , Engineering, and Regulatory Affairs. + Review and approve… more
- Globus Medical, Inc. (Audubon, PA)
- …ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Designing and developing ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and market plans + Assisting in the writing of regulatory applications to the FDA and other… more
- University of Utah (Salt Lake City, UT)
- …skills. + Previous experience in personnel management. + Must have experience with FDA regulatory writing and submissions including CMC sections, DMF , IND ... will be directed and overseen include the manufacturing and quality control of positron emission tomography ( PET )...control of radiopharmaceuticals. + Oversees and assists in preparing regulatory documents for submission to the FDA … more
- Stanford University (Stanford, CA)
- …multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal ... for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug… more
- Morehouse School Of Medicine (Atlanta, GA)
- …The role partners closely with the CRC Associate Director (Physician, Regulatory /Compliance & Fellowship Education) and the Quality /Compliance Core to ... on operational billing practices (policy ownership resides with Compliance/Associate Director). Regulatory & Quality Collaboration (Not Ownership) * Partner with… more
- AbbVie (Waco, TX)
- …and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements. ... with other departments such as the Device Analysis Lab, Quality Assurance, Regulatory Affairs, Clinical Studies, Customer...function in a cGMPs controlled environment regulated by the FDA and other competent authorities. + Ability to work… more
- Globus Medical, Inc. (Audubon, PA)
- …to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Design and develop ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and market plans + Assist in the writing of regulatory applications to the FDA and other… more
- Globus Medical, Inc. (Audubon, PA)
- …ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Designing and developing ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and market plans + Assisting in the writing of regulatory applications to the FDA and other… more
- J&J Family of Companies (Danvers, MA)
- …and collaborative leader capable of working across functions, including engineering, quality , regulatory , supply chain, and cybersecurity, to ensure the ... and patient safety. + Cross-Functional Collaboration: Work closely with R&D, Quality , Regulatory , Cybersecurity, Supply Chain, and Manufacturing teams to… more