- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs, is responsible for preparing, filing and gaining approval of ... PMA submissions to the US Food and Drug Administration ( FDA ) for class II and class III products. This...products. This position entails management of submissions to the FDA , requiring working knowledge of products under review and… more
- Dentsply Sirona (York, PA)
- …role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and ... technical files for CE marking. + Manages communications with FDA and EU notified bodies on behalf of the...EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and… more
- NTT DATA North America (Pittsburgh, PA)
- …apply now. NTT DATA's Client is currently seeking an IT Project Manager (dSME Program/Product) to join their team in Pittsburgh, Pennsylvania (US-PA), United ... States (US).REMOTE! Job Description: Project Overview The IT Project Manager will oversee multiple initiatives within the dSME (Digital Smart Manufacturing… more
- Oracle (Harrisburg, PA)
- …EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, ... Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- CSL Behring (King Of Prussia, PA)
- …therapies that make a meaningful difference worldwide. Could you be our next Senior Manager US Advertising and Promotion Lead? The job is in our King of Prussia, ... programming based on US Code of Federal Regulations and FDA implementing regulations and guidance. + Adhere to related...based on company practice, CSL policy, US law, and FDA regulations. + Collaborate with Commercial Operations Marketing, Legal,… more
- CVS Health (Blue Bell, PA)
- …the US public health in collaboration with Food and Drug Administration ( FDA ), academic institutions, and other health insurance companies. The SS&C team conducts ... research, medical chart review validations, and pragmatic research using the FDA Sentinel Common Data Model (SCDM), Sentinel and Distributed Research Network… more
- Oracle (Harrisburg, PA)
- …EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, ... Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable for driving timely and high-quality data management deliverables ... supporting the Olympus portfolio. The Sr. Clinical Data Manager designs, develops, and maintains key data management deliverables used to collect, review, monitor,… more
- Edwards Lifesciences (Allentown, PA)
- …+ As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior Manager , Medical Affairs) is responsible for ... a dynamic portfolio of products across TMTT. The Senior Manager will be an experienced medical device professional with...and EU MDR for clinical evaluations. + Experience with FDA PMA applications. + Strong knowledge of scientific research… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. +… more