- Merck & Co. (Durham, NC)
- …that manufacture, assemble, and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical, ... Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination… more
- Merck & Co. (Rahway, NJ)
- …cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse ... Building, Human Resource Management, Immunoassays, Immunology, Immunotherapy, Management Process, Medical Devices , Mentoring Staff, Ophthalmology, Pathophysiology, People… more
- Merck & Co. (Rahway, NJ)
- …and design verification testing to develop value-added solutions for medical devices and combination products.Build and enhance device or combination product ... and project management in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of experience in GxP-regulated IT system implementation, validation, and compliance in pharma/biotech/ medical device industry - Required 4+ years of proven ... systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality … more
- Merck & Co. (Rahway, NJ)
- …( our Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager, Engineer or AuditorExperience working with drug- device ... has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees… more
- Cardiovascular Institute of Central Florida (Lady Lake, FL)
- …documentation in electronic medical records (EMR). Ensure compliance with regulatory guidelines and best practices for device management. Proficiency of ... at our Tavares and The Villages locations. This role is essential in providing high- quality cardiac device monitoring and patient care in a dynamic and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of relevant experience preferredData management and/or related work experience in a medical device or pharmaceutical company, or similar environment (eg, CRO) ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and efficient utilization of the warehouse space. This individual will assist in regulatory inspections, perform safety and quality audits, and answer relevant ... Support the optimization and efficient utilization of the warehouse space.Assist in regulatory inspections, perform safety and quality audits, and answer… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …lift and manlifts, and hand and power toolsRepair of instrumentation, electrical devices , circuits, and switchgear used in cGMP and non GMP systemsInvestigate, ... thermal energy principals, mechanical maintenance techniques, and electromechanical theoryEnsures regulatory and job training remains current by promptly completing… more
- Synectics Inc (Dublin, CA)
- …processes between facilities. Strong knowledge of regulatory requirements and quality standards for medical device manufacturing. Excellent project ... methodologies. Engineering - Electrical or Mechanical preferable. Medical Device experience in manufacturing: preferably electrical mechanical devices .… more
- Michael Page (Beverly, MA)
- …on the production floor About Our Client The organization specializes in a niche medical device market that has continued to change lives across the world. ... If you are interested in being hands on and growing a career in the medical device space, APPLY TODAY! Job Description The Assembly Technician will be… more
- LanceSoft (Dublin, OH)
- …*Must be familiar with and comfortable using computers. *Working knowledge of the medical device regulatory procedures, lean manufacturing, and manufacturing ... The Assembler I position will inspect, weigh, package, and sort out defective medical devices as required. Essential Duties & Responsibilities *Keep work area… more
- AbbVie (Pleasanton, CA)
- …compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory ... our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to...experience. *Prefer at least three years of experience in medical devices , ideally class II devices… more
- AbbVie (North Chicago, IL)
- …contributes to the overall success of drug/ device development programs. Associate Director, Safety, Medical & Regulatory Quality is part of the R&D ... activities. The role covers AbbVie's entire portfolio of drug, device and cosmetics. The role ensures quality ...Agency inspections. The role reports to the Director, Safety, Medical & Regulatory Quality . There… more
- Masimo (Irvine, CA)
- …the incumbent will be a key person in making it happen. The incumbent's medical device regulatory expertise, organizational ability, and multi-tasking skills ... Knowledge of regulatory submission requirements for FDA Class II medical devices , and equivalent classification requirements for international submission;… more
- Zavation Medical Products LLC (Fenton, MO)
- …will be a member of a cross-functional team that includes engineering, manufacturing, regulatory , quality , and medical education. Responsibilities: Lead the ... in these functions. 5+ years of experience working in medical device , biotech, pharmaceutical or other regulated...regulated industry Demonstrated track record of leading product launches medical devices . Demonstrated ability to lead cross… more
- Atrium Medical (Hudson, NH)
- …the changes in compliance with Quality Systems Regulations (QSR), the Medical Device Directives, CMDR, and other International regulations. Participates in ... domestic, and international compliance activities working under the direction of the Regulatory Affairs Director. Assists the Regulatory Affairs Director with … more
- Abbott (Santa Clara, CA)
- …country-specific labeling) that meets international requirements for our medical devices . This role requires background in regulatory affairs and experience ... from a regulatory perspective. Strong knowledge of regulatory requirements for medical device ...of healthcare, with leading businesses and products in diagnostics, medical devices , nutritional and branded generic medicines.… more
- Michael Page (Merrimack, NH)
- …a growth focused environment About Our Client Our client is an established medical device manufacturer specializing in precision engineered products for the ... have: 5+ years of manufacturing engineering experience Experience in regulated industries ( medical device , aerospace, etc.) Proficient in SolidWorks and fixture… more
