- Merck & Co. (Rahway, NJ)
- …their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on ... development activities (eg engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture… 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. (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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position has experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry across multiple therapeutic areas and ... years of data management and/or related work experience in a medical device or pharmaceutical company, or similar environment (eg, CRO) required4+ years… more
- Lundbeck (New York, NY)
- …5+ years of Specialty Sales experience in Pharmaceutical, Biopharmaceutical, Biologics or Medical Device sales experience Ownership and accountability for the ... and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant includes clinical or basic research in a pharmaceutical company, a medical device /Diagnostic company, Academic Research Organization (ARO) or Contract ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant includes clinical or basic research in a Pharmaceutical company, a Medical device /Diagnostic company, Academic Research Organization (ARO) or Contract ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …responsible related experience; including hands on related pharmaceutical or medical device /pharmaceutical combination product experience and actual regulatory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and… more
- Catalent (MA)
- …Candidate Minimum of 3 years of sales experience in the bio, pharma, medical device industries, or other related industriesExperience in developing and ... exposure, defined career path and annual performance review and feedback processCompetitive Medical , Dental, Vision and 401K19 days PTO & 8 paid holidaysCatalent… more
- Lundbeck (Bronx, NY)
- …from an accredited college or university 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must ... procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or Bachelor… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting preferred- 4 or More Years Experience in ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and execute… more
- BioAgilytix (Durham, NC)
- …for Medical Devices, ISO 13485, FDA and (New) EU Medical Device requirementsCE Mark product certifications experienceDemonstrated project coordination and ... (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account ( medical ; dependent care), Short Term Disability | Long Term Disability Life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development and/or post marketing in clinical research, pharmaceutical, CRO or medical device setting required- Experience within oncology therapeutic area ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant includes clinical or basic research in a Pharmaceutical company, a Medical device /Diagnostic company, Academic Research Organization (ARO) or Contract ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Lundbeck (Rockford, IL)
- …from an accredited college or university 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must ... procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or Bachelor… more
- Catalent (Manassas, VA)
- …experience , required Experience working in an auditing role within the Pharmaceutical/ Medical Device industry Knowledge and understanding of the following ... (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices Working knowledge of industry related guidelines such as ICH… more
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