- Atlantic Health System (Morristown, NJ)
- …reports and documents all adverse events and serious adverse events per regulatory requirements, sponsor requirements and policies and procedures. + Writes study ... according to good clinical practices in research records. Maintains study drug/ device accountability records as required. Completes required case report forms in… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …complementary technology experience + Experience delivering technology solutions in a Medical Device or Pharmaceutical regulated environment + Solid knowledge ... of possible** BD is one of the largest global medical technology companies in the world. Advancing the world...of relevant Quality / Regulatory standards (cGxP, CFR Part 11, etc.)… more
- Sokol Materials & Services (Skillman, NJ)
- …+ Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing ishighly desirable. + Extensive knowledge of ... * Make decisions on non-conformances using a solid understanding of Quality Systems and regulatory requirements. * Review and approve documents related to … more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... of the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all… more
- Integra LifeSciences (Plainsboro, NJ)
- …costs, quality , and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the ... (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality of our medical devices. This includes...to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... of the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... and or post go-live support cases in compliance with the company's quality procedures. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a… more
- Agiliti Health (Paterson, NJ)
- … equipment management experts who proudly serve hospitals and healthcare facilities to ensure quality medical equipment is in the right place at the right time ... repairs, preventive maintenance and calibration. + Participate in hazard identification and medical device reporting procedures. + Instruct customer personnel on… more
- Sanofi Group (Morristown, NJ)
- …or PhD in LifeScience; Law or Computer Sciences + **Pharmaceutical, biotech, medical device industry experience required** + Demonstrated experience in working ... to generate deeper insights to our Research, Marketing, commercial and medical activities. + Actively monitor North American privacy regulations/enforcements, and… more
- Fujifilm (Wayne, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... **Position Overview** This position is responsible for technical repair and final quality inspection on assigned Endoscopic units. This position is responsible for… more