- 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
- 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
- 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
- Globus Medical, Inc. (Audubon, PA)
- … device industry, or equivalent. + Minimum of 3 years' experience in a regulatory capacity within the medical device industry, or equivalent, preferably ... At Globus Medical , we move with a sense of urgency...as quickly as possible. **Position Summary** **:** The Manager, Regulatory Affairs , is responsible for preparing, filing… 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
- Globus Medical, Inc. (Audubon, PA)
- …in medical device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus. + Excellent ... At Globus Medical , we move with a sense of urgency...lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting… more
- Pfizer (Collegeville, PA)
- …industry, preferably in Drug Development or Clinical Research, ideally within Regulatory Affairs + Subject-matter expertise within assigned therapeutic area ... to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Regulatory Affairs 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
- Globus Medical, Inc. (Audubon, PA)
- …candidate has deep experience in sales operations within the medical device or healthcare technology industry, understands the regulatory and logistical ... role in driving the commercial success of our global medical device business. This individual will partner...and ERP Systems. **Cross-Functional Collaboration** + Collaborate with Finance, Regulatory Affairs , Supply Chain, and Marketing to… 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
- Globus Medical, Inc. (Audubon, PA)
- …technique guides, brochures and other marketing/sales support materials + Partnering with Regulatory Affairs in planning, coordination, writing, and execution of ... role, you must possess the following:** + 8+ years' experience in the medical device product development and research field; 5+ years of people and or program… more
- Globus Medical, Inc. (Audubon, PA)
- …technique guides, brochures and other marketing/sales support materials + Partner with Regulatory Affairs in planning, coordination, writing, and execution of ... **the following:** + 5 years' minimum experience in product development in the medical device field, joint reconstruction experience is strongly preferred +… 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
