- Edwards Lifesciences (Allentown, PA)
- …Experience with FDA PMA applications. + Strong knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, ... Edwards Lifesciences is the leading global structural heart innovation company, driven by a...impact:** + As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal… more
- Eliassen Group (Harrisburg, PA)
- …risk management, and communication across all stakeholders. * Coordinate with Regulatory Affairs to ensure documentation and submission readiness for ... **Project Manager, Med Device , R&D PMO, Design Changes** **Anywhere** **Type:** Contract...modifications and component exchange programs while navigating a complex, global matrix organization. The project has completed feasibility and… more
- Pfizer (Collegeville, PA)
- **JOB SUMMARY** Global Regulatory Sciences (GRS) serves as strategic leader and catalyst enabling high quality, efficient, innovative, label-focused global ... within the assigned portfolio, and other disease areas as relevant including ensuring global regulatory strategies for all projects and products within the… more
- CSL Behring (King Of Prussia, PA)
- …delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other ... Regulatory CMC. + Proactively fosters and promotes effective relationships across Global Regulatory Strategy. Updates and maintains applicable regulatory … more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …CFR, Part 820, Quality System Regulation and ISO 13485 and all other applicable global regulatory requirements. The Global Vice President QARA Compliance is ... internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates...recommendations. + Coordinates and leads audit activities with all global regulatory agencies (eg FDA, Notified Bodies,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... an integral role in the day-to-day functioning of the global medical safety organization. In this vital role, you...+ Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs,… more
- Cook Medical (Vandergrift, PA)
- Overview The Regulatory Affairs Specialist - Post Market Surveillance Specialist 2 will be involved in the development and generation of post market surveillance ... Cook Distributor and Notified Body. Responsibilities * Maintain an excellent understanding of global medical device regulations for in relation to Post Market… more
- West Pharmaceutical Services (Williamsport, PA)
- …and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs , personnel, department resources, and continuous improvement ... device manufacturing. **Preferred Knowledge, Skills and Abilities** + ** Regulatory Skills:** In-depth knowledge of medical device ... / Pharmaceutical audits. + Able to interact with global Medical Device / Pharmaceutical agencies in… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …to ensure products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and for supporting business development ... roles and responsibilities of Quality Assurance. + Practical understanding of global regulatory /quality standards and requirements. + Potential for travel… more