- Merck & Co. (Rahway, NJ)
- …product performance test methods as needed in tech transfer or lifecycle.Experience with medical device development with understanding of Design Controls (21 CFR ... - ISO 14971, EU MDR, Medical Electrical Equipment - EN 60601, Medical Device Software Standard - IEC 62304, ISO 11608 Needle-based injection system for … more
- Merck & Co. (Rahway, NJ)
- …on-body infusers/injectors, inhalers, and more. As a subject matter expert in medical device and combination product design verification, the candidate will ... Engineering (or an equivalent field) + 3 years of experience in the medical device and/or combination product industry; or a Ph.D. in Mechanical Engineering (or… more
- Merck & Co. (North Wales, PA)
- …includes, but is not limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the ... and maintenance of technical business solutions, reviewing and approving medical device /combination product documentation to support regulatory filings… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …failures.Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Insmed Incorporated (Bridgewater, NJ)
- …In Plant (PIP).Responsible for QA representation in Design Control Process for medical device products and combination products.Lead the quality assessment for ... cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing and testing.Must perform… more
- Eisai, Inc (Nutley, NJ)
- …must include two or more of the following areas: infusion, diagnostic, biologic, medical device , buy and bill, rare disease, specialty pharmacy, and/or ... of internal success is required. A combination of infusion, diagnostic, biologic, medical device , buy and bill, rare disease, or specialty pharmacy experience is… more
- Merck & Co. (Rahway, NJ)
- …Preferred Experience: Product management experience with regulated Software as a Medical Device (SaMD), and/or Digital Pathology Experience commercializing and ... and/or healthcare space Understanding and experience with global regulatory requirements for Medical Device and/or AI algorithms Budget management and approval… more
- Merck & Co. (Rahway, NJ)
- …regulatory activities with cross- product or cross-functional impact, including drug device /combination products and software-as- medical device platforms.- ... advice to stakeholders creating optimal development, commercialization, and drug/delivery device supply strategies-Building our leadership and functional capability to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic ... more years data management and/or related industry work experience in a medical device , pharmaceutical company, or similar environment (eg, CRO) requiredDaiichi… more
- Aequor (TX)
- Job Description: Must Haves: Must have Medical Device experience. (Not Pharma) European MDR Experience Manufacturing background 4 Years of experience minimum ... of internal training and guidance to Site Regulatory Assessors on EU Medical Device Significant Change Notification reporting requirements Support the… more
