- 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
- Cardinal Health (Trenton, NJ)
- …in related field or equivalent work experience, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**... and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory … more
- GRAIL (Trenton, NJ)
- …, development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries is required. + Regulatory ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals is required.… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Globus Medical, Inc. (Audubon, PA)
- …work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product lifecycle + ... At Globus Medical , we move with a sense of urgency...**Position Summary** **:** Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance… 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
- 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
- Pfizer (Collegeville, PA)
- …communications plans/data dissemination in partnership with the Global, US, and International Medical Content Channel and Medical Affairs teams, integrating ... media solutions that align to the impact the Global Medical Affairs strategy and shape the digital...+ Liaise with Global and US internal stakeholders, including Medical , Regulatory , Digital Readiness Team (DRT), Commercial,… 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
- Wolters Kluwer (Philadelphia, PA)
- …a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This position is responsible for enabling engineering ... The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic… 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
- 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
- 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 (Spring House, PA)
- …and Device Development and Regulation, Presentation Design, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, ... (INTO) group, a cross-sector initiative at J&J, brings together the pharmaceutical and medical device expertise with the aim to meaningfully alter the course… more
- Philips (Mercerville, NJ)
- ** Medical Education Program Specialist** You will be responsible for the development, facilitation, execution, documentation, and monitoring of our customer-facing ... Structural Heart Disease (SHD) medical training and educational programs as part of a...forecasting, while maintaining vendor relationships and financial compliance. Uphold regulatory standards and audit readiness for all educational activities,… 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