- West Pharmaceutical Services (Exton, PA)
- …+ Attention to detail with planning, time management and organizational skills + Regulatory compliance competency including Quality Systems + Experience with ... and Technical Documentation for CE Marking. The Senior Specialist ensures timely and high- quality execution of all regulatory deliverables. In addition, the Sr.… more
- Deloitte (Philadelphia, PA)
- …automation of reporting processes, testing and validating reporting data, developing quality assurance programs, and remediating regulatory reporting issues + ... proposals The Team Our Regulatory & Financial Risk offering supports clients' regulatory and compliance needs, balancing risk and regulatory requirements… more
- Globus Medical, Inc. (Audubon, PA)
- …Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance . Monitors and improves tracking and control systems. ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
- Organon & Co. (Plymouth Meeting, PA)
- …**The Position** The successful candidate will collaborate with internal cross-functional project teams and alliance partners to develop and implement world-wide ... regulatory strategies for assigned biosimilar projects, with a specific...Manufacturing & Supply colleagues and external partners to ensure compliance execution of change management with a focus on… more
- Chemours (Harrisburg, PA)
- …Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw material components and/or 5+ ... teams including product development, business initiatives and market assessments ensuring regulatory and voluntary standard integration and compliance in… 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 ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
- Merck (Harrisburg, PA)
- …Improvement Programs, Quality Management, Quality Management Systems (QMS), Quality Operations, Regulatory Compliance , Regulatory Inspections ... or a related field. + 10+ years of progressive experience in Quality Compliance , preferably within large molecule manufacturing (biologics and/or vaccines).… more
- Merck (West Point, PA)
- …Auditing, Quality Compliance , Quality Management Standards, Quality Risk Management, Regulatory Compliance , Results-Oriented, Risk Management, ... and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering...Patients on time, every time, across the globe. The Quality Compliance Director will be a core… more
- J&J Family of Companies (Spring House, PA)
- …adherence to established policies, procedural documents, and templates. + Accountable for the quality of deliverables and for compliance of direct reports. + ... are searching for the best talent for a **Manager, Regulatory Medical Writing** to support one or more of...members on processes and best practices. + Potentially leading project -level/submission/indication writing teams. + If a lead writer for… more
- APTIM (Pittsburgh, PA)
- …+ Communications with regulatory agencies. + Time management to ensure a quality product is prepared to meet project deadlines. + Applies knowledge and ... APTIM Environmental & Infrastructure, LLC is seeking a mid-level ** Regulatory Hazardous Waste Specialist** on a full-time basis to...full-time basis to participate in a variety of environmental compliance tasks in support of our RCRA and state… more