- Veterans Affairs, Veterans Health Administration (Pittsburgh, PA)
- …into the CMMS. Ensure compliance with all applicable standards, policies, procedures, and regulatory requirements such as NFPA, FDA , NRC, TJC, and the AAMI. ... including National Fire Protection Association (NFPA), Food and Drug Administration ( FDA ), Nuclear Regulatory Commission (NRC), the Joint Commission (TJC),… more
- United Therapeutics (Harrisburg, PA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... in trust and collaboration. You naturally spot the needs of patients and healthcare providers, and you love coming up with thoughtful, strategic ideas that turn… more
- Wolters Kluwer (Philadelphia, PA)
- …planning, and defining and tracking success metrics. * Leverage knowledge of US healthcare government and regulatory published drug information and policy data ... machine-readable formats and SaaS-based solutions that power decision-making across the healthcare ecosystem. The Lead Product Manager translates customer and market… more
- Globus Medical, Inc. (Audubon, PA)
- …product managers to develop forecasts and market plans + Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + ... the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture...product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project… more
- University of Pennsylvania (Philadelphia, PA)
- …The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement ... coordination of study activities, including subject recruitment, data collection, regulatory documentation, and communication with internal and external collaborators.… more
- American Red Cross (Philadelphia, PA)
- …Spring Garden St. facility in Philadelphia, PA. The facility is regulated by the FDA . It is 245,000 square feet. **Experience working in an FDA -regulated, GPM ... issues, troubleshooting and problem solving as required. + Ensure all regulatory operations meet the minimum compliance standards. Maintain both the ongoing… more
- Sanofi Group (Swiftwater, PA)
- …Manager **Location** : Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and ... goals and priorities. Assures operations are conducted in compliance with regulatory authorities. Assures operations are conducted in compliance with cGMPs, CBER,… more
- Merck (North Wales, PA)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR… more
- Fujifilm (Harrisburg, PA)
- …II + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... as mentoring Clinical Consultant, MI I and II. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier… more
- Sanofi Group (Swiftwater, PA)
- …sponsor/monitor inspectorate activities. As such, they may interact with representatives of Regulatory Agencies ( FDA , MHRA, PMDA, NMPA, ANSM, EMA, etc.). ... support for project / study QRs as per need. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's… more
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