- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... to support the needs associated with training others on the operation of medical imaging equipment and conveying to the Fujifilm organization the status of the… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... the product sales, product marketing at a Healthcare / Medical Imaging / IT organization. + Broad functional experience...against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally...as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …education and experience. + Preferred minimum of ten-to-fifteen years of experience in the medical device industry, with at least nine years in a regulatory ... self. Become a **maker of possible** with us. The Regulatory Affairs (RA) Director is responsible for the management...legal); and negotiate with Regulators. + Ability to interpret medical device testing methods and statistics, as… more
- Cardinal Health (Trenton, NJ)
- …regulation) preferred * Experience in private practice strongly preferred * Familiarly with medical device and pharmaceutical regulation * Active license in good ... **_What Regulatory contributes to Cardinal Health_** Legal provides the...regulations; and other product-specific environmental / sustainability drug and device lifecycle obligations and stewardship programs. This role will… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Organon & Co. (Jersey City, NJ)
- …project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on ... Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role...CMC with demonstrated understanding of related pharmaceutical, biological or device operations (eg, manufacturing, process development, analytical, and quality… more
- United Therapeutics (Trenton, NJ)
- …), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee… more
- Integra LifeSciences (Plainsboro, NJ)
- …+ Strong knowledge of auditing techniques. + Minimum of 3-5 years of Medical Device , Pharmaceutical or related experience, preferably in FDA regulated industry. ... patient outcomes and set new standards of care. The **Internal Auditor, Regulatory Compliance** will have an in-depth understanding and knowledge of appropriate GMP… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and safety **Skills** + ** Regulatory Knowledge:** Extensive understanding of FDA medical device regulations (21 CFR Part 820), ISO standards (13485, 14971), ... in a critical role ensuring product safety and compliance in the medical device industry. **Responsibilities** + **Lead Post-Market Surveillance Activities:**… more