- 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 ... programs and resources, and much more. Posted Job Title Clinical Research Regulatory Affairs Specialist Job Profile Title Clinical Research Regulatory Specialist… more
- GE HealthCare (State College, PA)
- …+ Experience with medical device manufacturing or ultrasound technology. + Familiarity with regulatory standards such as ISO and FDA . + Project management ... **Job Description Summary** GE Healthcare is seeking a highly motivated and experienced...planning, purchasing and operations teams to ensure compliance with regulatory standards. + Leverage data to identify and implement… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …RA/QA representatives, healthcare providers, nurses, patients as well as external regulatory bodies, such as US FDA and notified body, concerning products ... reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and...A minimum of 3 years of experience on the healthcare /clinical setting or other points of care; OR +… more
- Guthrie (Sayre, PA)
- …+ Minimum 3-5 years of direct experience in clinical or pharmaceutical-sponsored research or regulatory fields such as the FDA , NIH, or HHS. + Minimum 5 ... basic science research that enhances patient outcomes and improves healthcare delivery within the Twin Tiers community and beyond....+ Advises The Guthrie Clinic senior leadership on HRPP regulatory issues. + Oversee FDA inspections, audits,… more
- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator ... The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement… more
- Merck (West Point, PA)
- …and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek ... performance testing. + ** Regulatory Compliance** : + Strong knowledge of relevant regulatory requirements such as ISO, USP, FDA guidelines, and other global … more
- Sumitomo Pharma (Harrisburg, PA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and… more
- Teleflex (Wyomissing, PA)
- …equivalent software. Regulatory and Compliance: * Familiarity with design control processes, regulatory requirements (eg, ISO 13485 and FDA 21 CFR 820) and ... of people's lives. Through our vision to become the most trusted partner in healthcare , we offer a diverse portfolio with solutions in the therapy areas of… more
- West Pharmaceutical Services (Exton, PA)
- …injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours ... and laboratory requirements. The role requires providing expert guidance on regulatory and industry standards concerning data integrity, including computer system… 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 ... communication with research team, including Investigators, project managers, CRC and regulatory team, to ensure patient safety and proper study conduct. Participate… more