- Merck (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of 10 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… more
- System One (Park Ridge, NJ)
- …advantage + Expert Microbiology and Sterilization understanding + Demonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC + Strong ... technical direction, leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through commercialization.… more
- Fujifilm (Trenton, NJ)
- …II + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... as mentoring Clinical Consultant, MI I and II. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier… more
- J&J Family of Companies (Titusville, NJ)
- At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, ... we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact… more
- Merck (Trenton, NJ)
- …including response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for ... comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement… more
- Integra LifeSciences (Plainsboro, NJ)
- …Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements. + Participate in FDA inspections, ISO ... chance to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every… 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 ... work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To...such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements. **Cross-Functional Collaboration:** + Work closely with sterility… 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 ... work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To...such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements. **Cross-Functional Collaboration:** + Work closely with sterility… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... to working in highly dynamic multi-vendor environment and stay up-to- date on healthcare and general IT trends, best practices, regulations, and a wide range of… more
- Cardinal Health (Trenton, NJ)
- …Cardinal Health is seeking a driven and skilled attorney with expertise in healthcare regulatory compliance, including third party billing and reimbursement. The ... for business clients. * Proactively develop and remain up-to-date on healthcare regulatory matters impacting the business, including current regulations,… more