- RWJBarnabas Health (West Orange, NJ)
- …academic and industry partners. The successful candidate will bring deep expertise in FDA regulations, IRB processes, HIPAA compliance in research, and federal ... years of legal experience, including substantial experience with clinical research, FDA regulatory compliance , and research contracting + Comprehensive knowledge… more
- embecta (Parsippany, NJ)
- …systems and operations comply with internal standards and regulatory requirements, including FDA and ISO standards. The Quality Compliance Auditor plays a ... **Responsibilities:** + Monitor the Quality Management System (QMS) to ensure compliance with FDA regulations, ISO 13485, ISO 14971, ISO 9001, MDSAP, EU MDR,… more
- Integra LifeSciences (Princeton, NJ)
- …Industry Experience is preferred. + Experience in a regulated environment: GxP, FDA , SOX Compliance + Strong communication and interpersonal skills ensuring ... in coordination with our Global Delivery Team and our Platform Leaders) + Compliance & Reporting + Communication skills to run Project Committees and Steering… more
- Bristol Myers Squibb (Princeton, NJ)
- …Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances + Ensure regulatory compliance with sub part e and 2253 ... BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances. **Responsibilities include:** + Provides regulatory advice,… more
- ManpowerGroup (Franklin Twp, NJ)
- …technical support to production units, outside vendors, and quality laboratories. + Ensure compliance with FDA and ISO guidelines, including SOPs, auditing, and ... manufacturing with a strong emphasis on quality. + Knowledge of FDA and ISO compliance standards. + Experience in auditing, documentation, and SOP adherence. +… more
- Integra LifeSciences (Princeton, NJ)
- …execute the requirements of Unique Device Identification (UDI) regulations for on-going global compliance (eg, FDA GUDID, EUDAMED, AUSUID etc.). + Develop and ... support for the Global Regulatory Affairs function and broader organizational compliance at Integra LifeSciences. To perform this job successfully, an individual… more
- Terumo Medical Corporation (Somerset, NJ)
- …+ Ongoing collaboration with medical, regulatory and legal partners to assure compliance with FDA regulations US laws and appropriate clinical representation ... + Demonstrate a commitment to patient safety and product quality by maintaining compliance with all TMC Quality Systems requirements. This includes but is not… more
- Actalent (Princeton, NJ)
- …quality data and metrics to identify trends and areas for improvement. + Ensure compliance with FDA , EMA, and other applicable regulatory standards for cell ... cGMP regulations (21 CFR Parts 210, 211, 1271), and relevant ICH and FDA guidance. + Demonstrated ability to lead and close complex quality investigations, including… more
- System One (Florham Park, NJ)
- …in development (including 2 new IND applications and 1 NDA) + Knowledge of and Compliance with FDA , EMEA, PMDA guidances + Performance will be monitored via ... + Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. + Excellent communication and interpersonal… more
- Integra LifeSciences (Princeton, NJ)
- …UAT support, and validation of planning outputs for compliance and accuracy. ** Compliance & Validation** Experience ensuring GxP, FDA , and other regulatory ... rollouts, and enhancements for large-scale Medical Device company, ensuring compliance with industry validation procedures & regulations. Possesses a strong… more