- Oracle (Trenton, NJ)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Bayer (Trenton, NJ)
- …As the Director of Regulatory Affairs , you will represent our medical device regulatory team within the Molecular Imaging platform. This pivotal ... are required + Direct professional experience in Regulatory Affairs within the medical device industry, with significant experience involving medical… more
- Bausch + Lomb (Trenton, NJ)
- …+ Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device , cosmetics or ... and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative...**We offer competitive salary & excellent benefits including:** + Medical , Dental, Eye Health, Disability and Life Insurance begins… more
- J&J Family of Companies (Titusville, NJ)
- …Johnson & Johnson is recruiting for a **Senior Finance Analyst - IM R&D Global Regulatory Affairs (GRA)** . This position can be located in Spring House, PA; ... financial support and leadership to the IM R&D's Global Regulatory Affairs (GRA), ~$200MM Opex budget and...skills are required. + Experience in the pharmaceutical or medical device industries is preferred. + The… more
- IQVIA (Wayne, PA)
- …data, etc.), HCP engagement by life sciences companies. Expertise in domains adjacent to medical affairs , such as regulatory or pharmacovigilance, would also ... **Manager, Medical Affairs Strategy** **Overview** IQVIA is...diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies as well… more
- Fujifilm (Trenton, NJ)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Bayer (Trenton, NJ)
- …radiopharmaceuticals as stand-alone and/or theranostic pairs, in a constellation of diagnostic medical device and software assets in the Radiology MI space ... project goals from development through life cycle; + Represents Global Regulatory Affairs on assigned global Project Teams; + Develops submission materials for… more
- J&J Family of Companies (Titusville, NJ)
- …publications emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug/ device regulatory strategies and ... interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality monitoring &… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of...Manufacturing and Controls (CMC), medical affairs and business development are critical… more
- J&J Family of Companies (Titusville, NJ)
- …and Device Development and Regulation, Program Management, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, ... via matrix interactions includes individuals from TA strategy, GCSO, global regulatory affairs , project management, finance, legal, quality assurance, quality… more
- University of Pennsylvania (Philadelphia, PA)
- …escorting participants to other testing/procedure areas.. . Coordinate several investigational device trials in the cath lab, instruct and support investigators and ... throughout the course of the study. + Creates and maintains research data, regulatory files, subject data and patient tracking databases. + Assures reported trial… more
- University of Pennsylvania (Philadelphia, PA)
- …of medical information from charts into online databases 2. Regulatory - preparation, submission and monitoring of human subject's protocols, and progress reports ... of medical information from charts into online databases 2. Regulatory - preparation, submission and monitoring of human subject's protocols, and progress reports… more
- University of Pennsylvania (Philadelphia, PA)
- …involving neuroimaging, blood biomarkers, neuropsychological assessment, and pharmacological and device interventions. TBIRI is seeking a detail-oriented and dynamic ... have prior experience conducting clinical research while adhering to applicable regulatory policies for patient and data protection. Responsibilities include, but… more
- University of Pennsylvania (Philadelphia, PA)
- …Development: Principal support in the development of Physician-Modified Investigational Device Exemptions (PS-IDE) and other clinical protocols for the Division's ... and informed consents documents in collaboration with faculty. + Regulatory -Financial-Training/Continuing Education: Negotiate clinical trial agreements and budgets; conduct… more
- University of Pennsylvania (Philadelphia, PA)
- …clinical trials. The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as ... to implement a plan of action. Work with the regulatory manager to ensure that submissions to the IRB...Life, and Flexible Spending Accounts : Penn offers comprehensive medical , prescription, behavioral health, dental, vision, and life insurance… more