- Fujifilm (Trenton, NJ)
- …others. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... into actionable user stories and system requirements. + Integrate input from regulatory , marketing, and implementation teams to maintain compliance and accuracy in… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties… more
- Sanofi Group (Morristown, NJ)
- …part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc ) and answers to questions from ... leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy… more
- Sanofi Group (Morristown, NJ)
- …+ Contribute to the clinical part of Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc.) and answer to questions from health ... leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy… more
- 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
- Stryker (Mahwah, NJ)
- …knowledge of MIM processes and tooling + Experience with process validation and regulatory compliance ( FDA , ISO 13485) Health benefits include: Medical and ... multiple manufacturing sites and collaborate closely with R&D, Manufacturing, Quality, Regulatory , and Supply Chain to deliver projects that meet medical device… 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** 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