- 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
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for ... Solid scientific background, PhD., MD, PharmD, MS + Significant experience in regulatory affairs and diagnostic-related development eg, >8-10 years. + Scientific… more
- ThermoFisher Scientific (Cranbury, NJ)
- …or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting and ... requirements and desired marketing claims. + Author and/or review regulatory submissions, specifically device master files, ...count on, which includes: + A choice of national medical and dental plans, and a national vision plan,… 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
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …engineering computer software and software updates. Ensuring compliance with the Safe Medical Device Act. Developing the work performance specifications for a ... (TJC), National Fire Protection Association (NFPA), or other applicable regulatory requirements. Ability to develop material for a continuing...to manage a recall and safety alert program for medical devices, including medical device … 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
- 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 (Princeton, NJ)
- …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
- 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
- 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device ), with 3-5 years in pharmaceutical quality, with specific experience ... TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs . **Disclaimer** This job description is intended to describe… more
- University of Pennsylvania (Philadelphia, PA)
- …operational barriers and escalate items requiring medical or regulatory decision-making. + Coordinate investigational product or device administration ... requirements; scheduling and conducting research visits in clinic; maintaining regulatory files; and preparing submissions to the Penn Biomedical Institutional… more
- Edwards Lifesciences (Trenton, NJ)
- …patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more
- Integra LifeSciences (Princeton, NJ)
- …intercompany loans ; + Providing product counseling and guidance on commercial and regulatory affairs initiatives to ensure compliance with applicable laws and ... with substantial experience supporting international business activities. Pharmaceutical or medical device industry experience preferred; + Comfort navigating… 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