- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Scientific Affairs group, an integral delivery unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable for driving ... management deliverables supporting the Olympus portfolio. The Sr. Clinical Data Manager designs, develops, and maintains key data management deliverables used to… more
- Organon & Co. (Plymouth Meeting, PA)
- …of industry experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least ... We are looking for an experienced Associate Director, Program Manager to join our team. This successful candidate will...drugs or devices which improve human health. The program manager may also be assigned to projects that contribute… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) ... more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** Manager , Quality Assurance External Manufacturing is responsible for managing… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …areas. + Execute global internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates audit corrective actions ... ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.**...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- CSL Behring (King Of Prussia, PA)
- …the guidance of the Publications Director, you will partner with Medical Affairs leaders, Compliance, Clinical, HEOR, and other functions to build efficient ... SOPs, and governance frameworks that ensure scientific integrity and regulatory compliance. You will also drive innovation in publication...provide first line support for junior team members (eg manager and sr manager ) + Lead operational… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …tracking, review, and collection of study-specific documents required in the site's Regulatory Binder. + Assist in tracking study activies and milestones by managing ... the Clinical Research Associate (CRA), Data Management and/or the Clinical Project Manager to ensure compliance with specified study protocols. + Oversee the design,… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... up to 10% of the time. **Essential Functions** **:** + Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …food is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs , you will play a crucial role in interpreting ... you will actively contribute to continuously developing and aligning our regulatory tools, including information systems, with our strategic objectives. You will… more
- Dentsply Sirona (York, PA)
- …business relationships. + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, ... Education: + Bachelor's degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. + Regulatory Certification (such as… more
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