- Integra LifeSciences (Plainsboro, NJ)
- …Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements. + Participate in FDA inspections, ISO ... the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies. **Primary responsibilities are:** **(Validations, Risk Management and… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …GxP compliance, Ethics & Compliance, and Pharmacovigilance, ensuring alignment with regulatory requirements and business objectives. This strategic leader will be ... engaging training ecosystem that enhances employee learning experiences and supports regulatory compliance. + Oversee the development and global deployment of… more
- Bristol Myers Squibb (Princeton, NJ)
- …a risk-based approach. **Key Responsibilities** * Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance metrics, and ... external signals, leveraging these insights to anticipate regulatory expectations, shape enterprise-wide inspection readiness strategies, and drive proactive,… more
- Oracle (Trenton, NJ)
- …with engineering and compliance teams to ensure process efficiency, regulatory alignment, and continuous improvement throughout the software development lifecycle ... We are looking for someone with demonstrated awareness of regulatory standards and hands-on experience integrating regulatory ...of healthcare regulations and standards relevant to software (eg FDA 21 CFR Part 820, ISO 13485:2016, EU MDR)… more
- Terumo Medical Corporation (Somerset, NJ)
- …the organization that includes Medical Affairs, Clinical Operations, Sales, Marketing, Regulatory Affairs, to ensure maximum exchange of information and insights. ... business partners. + Conduct all activities in accordance with current regulatory and health care compliance guidelines. + Provide high-level research support… 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
- Astrix Technology (New Brunswick, NJ)
- …and clean steam systems operate reliably, efficiently, and in full regulatory compliance to support continuous manufacturing operations. The ideal candidate will ... accurate, compliant documentation in accordance with SOPs, GMP, and FDA regulations. + Collaborate cross-functionally with Facilities, Engineering, and Quality… more
- Hackensack Meridian Health (Red Bank, NJ)
- …programs with 12 years BMET work experience. + Demonstrated understanding of FDA , Joint Commission, CMMS, and NJDOH standards. + Demonstrated understanding of ... computerized maintenance management systems + Demonstrated ability to access public FDA 510k information about patient care medical devices. + Demonstrated knowledge… more
- BeOne Medicines (Pennington, NJ)
- …and release of materials, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... Establishes and implements QC Physicochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of… more
- System One (Fairfield, NJ)
- …teams require immediate decisions. Strong 1st-shift QA coverage is essential to maintain FDA , HACCP, GMP, and customer compliance as production ramps up across the ... and incubators + Interpret, document, and communicate microbiological findings Food Safety & Regulatory Compliance + Follow and enforce GMP, HACCP, and FDA food… more