- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …responsible for leading and maintaining the Post - Market Surveillance program in compliance with EU MDR, EU IVDR, Health Canada, China and UKCA requirements. This ... ensures continuous monitoring of product performance, safety, and regulatory compliance throughout the product lifecycle. The individual collaborates cross-functionally… more
- Catalent Pharma Solutions (Princeton, NJ)
- …testing, support method development/validation, and ensure audit readiness. + Maintain compliance with SOPs and regulatory requirements ( FDA , EMA, cGMP) ... This role demands a thorough understanding of regulatory requirements and compliance with standard operating procedures (SOPs). Additionally, the QC Scientist will… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …procedures to ensure that the business units quality management and compliance program are effective and efficient in identifying, detecting, and correcting ... non- compliance and mitigating risks, The performance of the Quality...Bachelor's degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment +… more
- Hovione (East Windsor, NJ)
- …equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes ... providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications. - In the early designing… more
- Taiho Oncology (Princeton, NJ)
- …materials and scientific exchange communications, reporting to the Company's Compliance Officer. Performance Objectives: + Understand and collaborate with business ... promotion, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best… more
- Merck (Rahway, NJ)
- …and issues related to submission content management, quality and standards compliance + Engage across functional areas to identify opportunities for improvement; ... years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a… more
- Merck (Rahway, NJ)
- …packaging process and equipment issues, optimizing processes, and ensuring compliance . Effective collaboration with site-based and above-site based functional teams ... requires advanced skills in creating and improving business, technical, and compliance processes, and leading high-impact cross-functional teams. + Responsible to… more
- Merck (Rahway, NJ)
- …enhance data monitoring capabilities, and drive excellence in safety, compliance , supply, and productivity. **Global Impact:** Collaborate with colleagues across ... regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies ( FDA , EMA, JNDA, TGA). + **Leadership:** Establish and manage Cell Banking… more
- Integra LifeSciences (Plainsboro, NJ)
- …as performs environmental monitoring. This position is responsible for operating in compliance with all applicable procedures and policies **This is a second shift ... shift Monday-Friday 8:00am-4:30pm. **ESSENTIAL DUTIES AND RESPONSIBILITIES** + Ensure compliance with all company policies and procedures and appropriate… more
- Penn Medicine (Plainsboro, NJ)
- …effectiveness targets and strategies annually (part of budget process). + Regulatory Compliance : Ensures all areas of accountability are compliant with all federal, ... state and local regulatory standards and requirements, including DOH, TJC, FDA , HIPAA, HCFA, DPW, OSHA and others for practices under their leadership. Complies with… more