- Integra LifeSciences (Princeton, NJ)
- …and validation of bacterial endotoxin control programs, ensuring compliance with relevant regulatory requirements such as ANSI/AAMI ST72, ISO 11737-3, USP <85>, USP ... <161>, and FDA guidelines. + Ensure proper integration of endotoxin testing...risks from both a product and patient safety perspective. ** Regulatory Compliance & Documentation:** + Ensure thorough documentation and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …regarding audit outcomes and CAPAs. Beyond auditing, this role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership ... improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals while contributing to the overall quality… more
- Atlantic Health System (Union, NJ)
- …compliance. + Provides remediation as indicated. + Participates in in-services as required. REGULATORY COMPLICANCE (CAP, CLIA, JCAHO, FDA ) + Updates and monitors ... inquiries off hours. + Ensures that technical manuals are in compliance with all regulatory agencies. + Performs duties of testing personnel as needed. + Cover any… more
- Bayer (Whippany, NJ)
- …Medicine Advanced Therapy (RMAT) designation by the US Food & Drug Administration ( FDA ). AB-1005 is a gene therapy, which has also been granted Fast Track ... designation by the US FDA . While entry into any new therapeutic area requires...shaping the hospital and thought leader network, anticipating US regulatory considerations, building the cross-functional team, and other aspects… more
- 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
- Integra LifeSciences (Princeton, NJ)
- …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + This position ... industry standards such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements. **Cross-Functional Collaboration:** + Work closely with sterility assurance and… more
- Integra LifeSciences (Princeton, NJ)
- …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + This position ... industry standards such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements. **Cross-Functional Collaboration:** + Work closely with sterility assurance and… more
- AbbVie (Florham Park, NJ)
- …R&D organization in navigating enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative products to patients. ... leaders within the R&D and corporate strategy organizations on legal and regulatory issues that impact pipeline development, government agency engagement and product… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** Act as the primary… more
- J&J Family of Companies (Titusville, NJ)
- …globally. Through this approach, we have become the industry leader in productivity, FDA approvals and breakthrough designations, with 13 new products since 2011 and ... and for final protocols, clinical study reports, and clinical components of regulatory packages/submissions. He or she may delegate some of these responsibilities,… more