- Insight Global (Philadelphia, PA)
- …devices and systems, including diagnostic, therapeutic, and life-support equipment. -Expertise in regulatory compliance (eg, FDA , Joint Commission, NFPA, ... lifecycle including acquisition, installation, preventive maintenance, and decommissioning. - Ensure compliance with regulatory standards (eg, FDA , Joint… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance . Performs routine assignments independently; supports ... reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and...requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents… more
- UPMC (Pittsburgh, PA)
- …**Responsibilities:** + Manage purchasing and inventory control, ensuring cost-effective practices and regulatory compliance (DEA, JCAHO, FDA , USP, OSHA, ... etc.). + Supervise pharmacy operations, personnel, and service quality across centralized and decentralized areas. + Coordinate staffing and scheduling to maintain optimal care delivery and patient safety. + Support recruitment, training, performance… more
- Jabil (West Chester, PA)
- …and foster vibrant and diverse communities around the globe. Are you experienced in Regulatory Compliance ? Jabil is seeking a qualified Regulatory ... Manager to work in West Chester, PA. As the Regulatory Compliance Manager, you will manage all...audits: eg Notified Body, Ministry of Health country inspections, FDA , J&J Corporate Audits for site. + Audit preparation… more
- Charles River Laboratories (Wayne, PA)
- …working relationship with site/operation management to assure a cohesive approach to regulatory compliance . ⦁ Assure staff receives appropriate regulatory ... River operations and serves as a member of the Regulatory Affairs and Compliance management team. Provides...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Organon & Co. (Plymouth Meeting, PA)
- …products, in order to optimize label and obtain shortest time to approval by regulatory agencies, including but not limited to US- FDA or EU procedures ... + Represent our company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies, including telephone calls… more
- Globus Medical, Inc. (Audubon, PA)
- …needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine ... as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Globus Medical, Inc. (Audubon, PA)
- …needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- J&J Family of Companies (Horsham, PA)
- …subject to applicable laws, regulations, guidelines and company policies (including FDA regulatory promotional practice laws, regulations, policies, guidelines ... pharmaceutical or biopharmaceutical industry is required. + Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and… more
- Globus Medical, Inc. (Audubon, PA)
- …needed for IDE and PMA reporting + Reviewing Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performing routine ... lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more