- J&J Family of Companies (Raritan, NJ)
- …& Johnson is currently seeking a Site Based Compliance Manager to join our Regulatory Compliance team located in Raritan, NJ. The **Site Based Compliance ... ensures understanding and alignment of the site to global regulatory compliance initiatives and executes local programs...experience is required. + Knowledge of cGMP regulations and FDA /EU Guidance related to the manufacture of biologics or… more
- Catalent Pharma Solutions (Princeton, NJ)
- …and ensure audit readiness. + Maintain compliance with SOPs and regulatory requirements ( FDA , EMA, cGMP) by documenting results, supporting audits, and ... continuous improvement initiatives. This role demands a thorough understanding of regulatory requirements and compliance with standard operating procedures… more
- Integra LifeSciences (Princeton, NJ)
- …ensuring full compliance with US Customs and Border Protection (CBP), FDA , and other government agency regulations for both imports and exports. This position's ... set new standards of care. The **Import/Export Compliance Specialist** plays a critical role in...+ Assist with maintenance of import/export programs. + Monitor regulatory changes affecting import and export regulations, and surface… more
- BeOne Medicines (Pennington, NJ)
- …authoring and vendor qualification. + Development of all necessary SOPs, ensuring regulatory compliance in conjunction with being appropriate both clinical and ... **_General Description:_** Responsible for the design, implementation, and management of Compliance programs for the Hopewell, NJ site. Programs which require… more
- Integra LifeSciences (Plainsboro, NJ)
- …to advance patient outcomes and set new standards of care. The **Quality Compliance Specialist** will provide quality compliance support to the Collagen ... that the development, manufacture and distribution of medical products are in compliance with company policies and procedures, US. Food and Drug Administration… more
- Integra LifeSciences (Princeton, NJ)
- …for compliance and accuracy. ** Compliance & Validation** Experience ensuring GxP, FDA , and other regulatory compliance in Life Sciences supply chain ... rollouts, and enhancements for large-scale Medical Device company, ensuring compliance with industry validation procedures & regulations. Possesses a strong… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and education regarding customer complaint processing, MDR's, complaint report ability, and regulatory compliance . + Fills out decision trees when needed, after ... reviews and approves. + Generates MDR reports in accordance with BD procedures and FDA regulations. **To be successful in this role, you should be able to… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …and respond to signal analysis, and submit to regulatory agency ( FDA /Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance ... regulatory norm + Anchor drug safety regulatory inspection in US ( FDA regulatory...up. Establish the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements + Review… more
- Merck (Rahway, NJ)
- …manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek out, ... testing. + ** Regulatory Compliance ** : + Strong knowledge of relevant regulatory requirements such as ISO, USP, FDA guidelines, and other global … more
- Sumitomo Pharma (Trenton, NJ)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions,...clinical study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with… more