- Integra LifeSciences (Plainsboro, NJ)
- …established costs, quality , and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the ... and maintenance problems to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all… more
- Integra LifeSciences (Plainsboro, NJ)
- …established costs, quality , and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the ... and maintenance problems to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all… more
- Oracle (Trenton, NJ)
- …customer expectations, and industry best practices. + Guide the integration of regulatory and quality requirements into software development practices and ... designing, optimizing, and governing software development processes to deliver high- quality , compliant, and effective healthcare technology solutions. This role… more
- Sanofi Group (Morristown, NJ)
- …leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies, ... Head partners closely with clinical teams, Clinical Sciences & Operations (CSO), regulatory experts, and key stakeholders to accelerate the delivery of medicines to… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …+ **Governance & Compliance** + Ensure all training programs meet global regulatory requirements and internal quality standards. + Monitor training effectiveness ... biotech, or healthcare industry. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …timelines to ensure compliance with labeling regulations and guidance. Delivers high- quality submission labeling and artwork for complex drug products, specific ... to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global… more
- Wolters Kluwer (Princeton, NJ)
- …engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. ... and managing the software development plan and partnering with engineering, quality , and regulatory team members to aligning the process with agile and lean… more
- Bristol Myers Squibb (Summit, NJ)
- …years of leadership/managerial experience required. + Experience in participating and supporting regulatory audits preferred: FDA , MHRA, PMDA, etc. + Experience ... Sterility Assurance is responsible to act as the SME during regulatory inspections. **Duties/Responsibilities** + To support final product testing and release,… more
- BeOne Medicines (Pennington, NJ)
- **General Description:** Manages all Quality Control (QC) laboratory instrumentation and metrology activities to support GMP manufacturing, testing, and release of ... materials, intermediates, and finished products under FDA /EU regulations, applicable international regulations, and BeOne processes and procedures. Ensures GMP… more
- Stryker (Mahwah, NJ)
- …in CAD software (SolidWorks, Creo) + Familiarity with validation protocols and regulatory compliance ( FDA , ISO 13485). Health benefits include: Medical and ... & Validation: + Execute IQ/OQ/PQ validation protocols to ensure compliance with FDA and ISO 13485 standards. + Establish robust process controls and capability… more