- Sanofi Group (Morristown, NJ)
- …clinical part of regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA) and answers to questions from health ... scientists in the project in collaboration with the Safety Officer, Regulatory Strategist, Statistics and other key functional representatives to deliver development… 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
- Merck (Rahway, NJ)
- …process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485, ... of key quality and compliance programs to identify gaps against internal standards, regulatory expectations (eg, FDA , EMA), and industry best practices, generate… more
- Stryker (Mahwah, NJ)
- …in CAD software (SolidWorks, Creo) + Familiarity with validation protocols and regulatory compliance ( FDA , ISO 13485). Health benefits include: Medical and ... + Execute IQ/OQ/PQ validation protocols to ensure compliance with FDA and ISO 13485 standards. + Establish robust process...production risks. + Maintain DHF and DMR documentation for regulatory compliance. + Drive Lean and Six Sigma initiatives… more
- Abbott (Newark, NJ)
- …product developments * Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures, ... processes, and task assignments * Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors * Performs other related duties and responsibilities, on occasion, as assigned… 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 all other applicable laws, regulations, and standards. **Qualifications:** + BA/BS or equivalent professional work experience + A minimum of (5+ years desired) full-time experience in PACS System Administration (FUJIFILM Synapse preferred) or equivalent… 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 all other applicable laws, regulations, and standards. **Qualifications** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill,… 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 all other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience + 4+ years previous… more
- Fujifilm (Wayne, NJ)
- …required + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... and all other applicable laws, regulations and standards. **Qualifications:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill,… more
- Fujifilm (Wayne, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... and all other applicable laws, regulations, and standards. + Must follow instructions and apply to real situations in a very quick manner. + Reach monthly targets on a consistent basis. **Qualifications:** + HS Diploma or equivalency is required. + Electronic… more