- PCI Pharma Services (Philadelphia, PA)
- …network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives involving matters of ... government and regulations, with respect to the FDA , DEA, MHRA, EEU, State of Illinois, and..., DEA, MHRA, EEU, State of Illinois, and other regulatory agencies. This position hosts audits for current and… more
- GE HealthCare (State College, PA)
- …communication, and stakeholder engagement skills. **Preferred Attributes** + Experience with FDA , ISO 13485, and healthcare regulatory standards. + Familiarity ... optimization across supply chain functions. Enable scalable production and regulatory compliance through advanced manufacturing technologies. **Key Responsibilities** +… more
- ICON Clinical Research (Blue Bell, PA)
- …the pharmaceutical, biotechnology, or CRO industry. + Expert knowledge of regulatory requirements, including FDA /EMA regulations, ICH-GCP guidelines, and ISO ... comprehensive quality management systems and processes to ensure compliance with regulatory requirements, industry standards, and company policies. + Lead internal… more
- Cytel (Harrisburg, PA)
- …with a strong foundation in statistics. + Demonstrated experience interacting with regulatory agencies (eg, FDA , EMA) and contributing to health authority ... machine learning), with experience across all phases of development and global regulatory interactions. We are seeking an **Executive Consultant** - a seasoned… more
- Oracle (Harrisburg, PA)
- …**Oracle Cloud SCM, Manufacturing, Quality, and ERP** integrations. + Knowledge of ** regulatory compliance processes** ( FDA , ISO, cGMP) and quality documentation ... management. + Familiarity with **Oracle Visual Builder Studio** , **BI Publisher** , and **Reports** for PLM analytics. + Certification in **Oracle Cloud PLM or PDH** modules. + Strong understanding of **product data governance frameworks** and enterprise data… more
- TreeHouse Foods, Inc. (Womelsdorf, PA)
- …quality systems and initiatives. + Serve as the plant's liaison for regulatory authorities, including USDA, FDA , and third-party auditors. **_Important ... quality, food safety, and sanitation in compliance with company standards and regulatory requirements. **_You'll add value to this role by performing various… more
- Wolters Kluwer (Philadelphia, PA)
- …engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. ... managing the software development plan and partnering with engineering, quality, and regulatory team members to aligning the process with agile and lean engineering… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …systems and leading cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Expertise in LMS ... end-to-end management of global training operations, ensuring compliance with regulatory requirements, operational efficiency, and alignment with corporate quality… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in… more
- BD (Becton, Dickinson and Company) (Zelienople, PA)
- …and improving the company's Quality Management System (QMS) to ensure compliance with FDA , ISO 13485, and other applicable regulatory requirements. This role is ... efficiency, and enhance usability of quality systems. + Support internal audits and regulatory inspections as a process owner or SME. + Contribute to the development… more