- Merck (West Point, PA)
- **Job Description** The Associate Director - Device Tech Transfer is a leadership role within the Device Development and Technology Organization. ... and combination products, with a focus on autoinjectors, prefilled syringes, and other drug deliverysystems. The Associate Director will collaborate with a… more
- Merck (West Point, PA)
- …** Associate Principal Scientist - Device Technical and Engineering Lead ( Associate Director Equivalent)** _Our company's Device Product & Process ... Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and effective… more
- GRAIL (Trenton, NJ)
- …position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual ... 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings. + Serve as a key member of the Regulatory… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret the ... EFPIA, JPMA, etc.). + Demonstrate solid working knowledge of the drug , biologic, and device development process, laws, regulations, and guidelines from FDA, EMA,… more
- Guidehouse (Philadelphia, PA)
- …particularly for specialty medications (eg, high cost, biologics, CAR-T, REMs, drug - device combinations), Organizational design and change management, and ... design, implementation, and monitoring services to pharmaceutical, biotechnology, and medical device , companies. We support our clients across the lifecycle of a… more
- Fujifilm (Trenton, NJ)
- …safety policies and procedures. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO ... **Position Overview** The Associate Clinical Specialist independently provides customer support of...required. This position reports directly to the Zone Sales Director or Regional Manager. **Company Overview** At FUJIFILM Healthcare… more