- 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
- Medline Industries LP (Columbus, OH)
- …biocompatibility processes. This position is responsible for the biological evaluation of medical device , OTC, and cosmetic products, including the conduct of ... toxicological risk assessments in support of new product development and sustaining activities, as well as in support of global regulatory submissions. This position ensures product safety and leads risk mitigation efforts and is responsible for the conduct of… 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Catalent (St. Petersburg, FL)
- …years auditing experience Experience working in an auditing role within the Pharmaceutical/ Medical Device industry, required Knowledge and understanding of the ... ISO, and related International Regulations affecting pharmaceutical products and medical devices Sterile/biologic/ATMP/C> auditing experience preferable Working knowledge of… more
- Catalent (St. Petersburg, FL)
- …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
- 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 ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...(CRO). CRA experience preferred- Time spent directly in a medical environment (eg as a Study Site Coordinator) is… more
- Lundbeck (Dallas, TX)
- …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
- 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
- Novo Nordisk Inc. (Durham, NC)
- …of QA and/or cGMP related experience required, preferably in the pharmaceutical or medical device industry General knowledge of Batch Review Processes (BRP), ... 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases,...12 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products… more
