- CoWorx Staffing Services (Alpharetta, GA)
- CoWorx Staffing Services, is searching for Medical Device Assemblers in the Alpharetta, GA area! Responsibilities:*Adhere to and follow work instructions to ... FDA requirements * Previous manufacturing, production or assembly experience * Previous medical device or FDA regulated industry experience preferred Other… more
- 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
- Nesco Resource (New Haven, CT)
- …regulatory requirements You will need to have: Experience in commercialization of medical device and/or combination products Deep knowledge of regulatory and ... Demonstrated ability to facilitate the interface among the pharmaceutical company, the medical device vendors, and HF consulting firms Strong communication,… more
- Nesco Resource (Rochester, NY)
- …BA/BS degree or equivalent is required; a degree with a science concentration is preferred.Previous laboratory or similar experience is preferred.This position ... requires flexibility between A-shift (~7:00am -3:30pm) and B-shift (1:30pm -10:00pm) Monday-Friday.Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type… 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
