- IQVIA (Washington, DC)
- …significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in ... area guidance for clinical development plans in compliance with applicable regulatory , medical, and ethics guidelines. + Ensure high- quality , data-driven… more
- Bayer (Berkeley, CA)
- …Audit & Observation management, Risk Management, etc.); + Expertise in cGMP and regulatory requirements ( FDA , EMA, ICH, etc.); + Expertise in performing ... in managing all aspects of investigations; * Maintain knowledge of current regulatory practices including a current understanding of USP/EP, cGMP regulations, ICH,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …creation and execution of Human Factors documentation to ensure compliance with regulatory requirements in alignment with the business strategy of the company. This ... need it. + Be the point of contact for regulatory body audits and communications for the region. +...Factors in Medical Device and healthcare regulations including the FDA 2016 Guidance, 'Applying Human Factors and Usability Engineering… more
- Stanford Health Care (Palo Alto, CA)
- …Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, special programs, ... federal and state levels. + Knowledge of other relevant regulatory guidelines (eg, CMS, 340B, FDA ). +...the very best in diagnosis and treatment, with outstanding quality , compassion and coordination. With an unmatched track record… more
- Atlantic Health System (Summit, NJ)
- …compliance. + Provides remediation as indicated. + Participates in in-services as required. Regulatory Compliance (CAP, CLIA, JCAHO, FDA ): + Updates and monitors ... reports workload statistics to the Site Manager. + Reports Quality Control, Proficiency Testing and Quality Improvement...Ensures that technical manuals are in compliance with all regulatory agencies. + Performs duties of testing personnel as… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and quality . + Collaborate closely with product management, hardware engineering, quality assurance, and regulatory affairs teams to ensure alignment and ... software development teams in the medical device industry, with a strong understanding of regulatory requirements (eg, FDA 21 CFR Part 820, IEC 62304). +… more
- Sutter Health (Santa Cruz, CA)
- …at external facilities, and in the community to provide seamless and integrated quality care + Performs one or more of the following: + Second-level controlled ... requirements with ability to optimize procurement strategies while meeting regulatory requirements + Analyze reports/processes and the administrative functions… more
- Merck (West Point, PA)
- …life while ensuring compliance with FDA , EMA, and other regulatory requirements. + Collaborate closely with Quality Assurance, Validation, Manufacturing, ... teams. + Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements ( FDA , EMA, GMP). + Expertise in reliability… more
- Abbott (North Chicago, IL)
- …(WMS), inventory control, and transportation logistics. + Strong knowledge of healthcare regulatory & Transportation requirements ( FDA , GMP, GDP, IATA, DOT) + ... safety, and people leadership with fostering a culture of Quality , Safety, employee engagement and continuous improvement. **Responsibilities** + **Operational… 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 + Designs and develops ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and market plans + Assists in the writing of regulatory applications to the FDA and other… more