- Legend Biotech USA, Inc. (Raritan, NJ)
- …degree or higherA minimum of two (2) years related experience in medical device , biopharmaceutical, or pharmaceutical industryA degree in Biology, Biochemistry, ... tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some sophisticated issues. He/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to proposed business plans.- Communicate ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Integra LifeSciences (Princeton, NJ)
- …and International requirements as defined in FDA Regulations, ISO Standards, European Medical Device Directives, and other International Regulations. This role ... Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU ...complex problems that have a broad impact on the business Document Control and Training Administration: + Provide strategic… more
- Integra LifeSciences (Princeton, NJ)
- …data, monitoring, and maintaining the sterility assurance used in Tissue Technology medical device manufacturing. The candidate must have experience managing as ... well as interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of… more
- Terumo Medical Corporation (Somerset, NJ)
- …TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide ... and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business...manner. + Effective communication, both written and verbal, with technical and non- technical multi-functional teams spread across… more
- Terumo Medical Corporation (Somerset, NJ)
- …TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide ... and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business...Collaborate with finance, operations, and IT stakeholders to translate business needs into technical solutions. Actively contribute… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …**Minimum work experience:** 8+ years of progressive experience in auditing pharmaceutical or medical device systems, including 2 years of internal and external ... + Strong understanding of pharmaceuticals, with a combination product or medical device manufacturing, packaging and testing processes, and management… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …within the guidelines of 21 CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other ... applicable standards, laws and regulations wherever we do business . **Work Conditions:** + Office + Lab + Manufacturing...required **Experience:** + 7 years of experience in the medical device industry and/or biomedical field preferred… more
- Integra LifeSciences (Plainsboro, NJ)
- …and control systems related to manufacturing and utility equipment in a cGMP medical device manufacturing plant. The position will be responsible for conducting ... of 5 years work experience in facility equipment maintenance preferably in the Medical device or Pharmaceutical industries + Knowledge of operation and… more
- Integra LifeSciences (Princeton, NJ)
- …understanding compliance. + Experience in highly regulated industries required, medical device and/or pharmaceutical preferred, including material remediation ... **Requirements** + Bachelor's degree is required, (Engineering, Science or closely related technical discipline is preferred) + 10+ years of experience leading a… more
- Capgemini (Bridgewater, NJ)
- …alignment **What you will bring** **:** + 7+ years ofexperience as a technical Business Analyst in Life Sciences, MedicalDevices, or Digital Health Solutions ... do at Sogeti** **:** + Partner withstakeholders across product, engineering, and business units to gather anddocument functional and technical requirements +… more
- Oracle (Trenton, NJ)
- …safety-critical systems is a must. **Responsibilities** **Responsibilities:** As a Principal Member of Technical Staff for Medical Device Software, your key ... for designing and governing architectures in complex, safety- or compliance-critical systems ( medical device experience preferred). + Technical Expertise +… more
- Oracle (Trenton, NJ)
- …success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with ... applications used in clinical operation, clinical information systems, and clinical decision support ( medical device and non- medical Device ). You will… more
- Oracle (Trenton, NJ)
- … Device Integration team is comprised of four main products including Bedside Medical Device Integration (BMDI), Laboratory Medical Device Integration ... consulting implementation services to clients throughout North America for our medical device connectivity products. These services include the integrated… more
- Sargent & Lundy (Hamilton, NJ)
- …overall company with business development as well as serving on industry technical committees. + This position requires an extensive knowledge base and skill set ... will support a wide range of FACTS projects providing technical leadership. Project tasks may include client support on...Engineer, you will be responsible for proactively guiding the business related to FACTS device standards, codes,… more
- Oracle (Trenton, NJ)
- …Report status, device health, risk, and improvement opportunities clearly to technical management, business partners, and senior leadership. **KEY SKILLS AND ... + Outstanding communication, troubleshooting, and stakeholder management skills across technical and business audiences. \#LI-KNC2 Disclaimer: **Certain US… more
- Oracle (Trenton, NJ)
- …role will help ensure **operational alignment with international compliance frameworks and medical device regulatory requirements** as HDI scales its solutions ... Certification:** Collaborate with legal, regulatory, and product stakeholders to support ** medical device certification and compliance activities** as HDI… more
- Oracle (Trenton, NJ)
- **Job Description** **Senior Federal Technical Project Manager - General** We're on a journey to advance how health happens with technologies that support ... to the right place. Advance Healthcare with Technology-Join Us as a Federal Technical Project Manager **About the Role** Oracle Health Government is seeking an… more
- Oracle (Trenton, NJ)
- …that enhance security or automate processes. + Produce and maintain technical and procedural documentation-covering device standards, installation and escalation ... and cloud infrastructure across the globe. We are seeking a skilled Technical Program Manager to lead the end-to-end strategy, development, and evolution of… 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 ... **Position Overview** The Senior Technical Support Engineer, MI - I (Tier 1)...meet the needs of our customers, working outside normal business hours and on some weekends/holidays is required. In… more
