- Merck & Co. (Rahway, NJ)
- …Reporting to the Director responsible for this area, you will partake in medical device assembly and process development using semi-automated and automated ... as needed. Key Responsibilities: Experience with, and a fundamental understanding of medical device assembly equipment to enable development of product specific… more
- Aequor (Thousand Oaks, CA)
- …Client yet practical solutions to meet those needs Experience with combination products and device regulatory requirements and medical device development ... and engineering Preferred Traits: Passion for proactively identifying opportunities through creative modeling and data analysis Transform ambiguous business and technical questions into measurable and impactful projects Partner with multi-discipline digital… 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 ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …failures.Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for ... retention, testing and retesting of samplesProject Team Participation: Provide device -specific regulatory insight/guidance during CDx Indication Team Working… 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 ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… 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 clean.… more
- Abbott (Santa Clara, CA)
- …design and development from a regulatory perspective. Strong knowledge of regulatory requirements for medical device labeling. Proficiency in SAP ... skills. PC and Microsoft Office experience. Preferred Qualifications: Experience with medical device labeling or labeling for highly regulated industry… more
- Merck & Co. (Rahway, NJ)
- …advanced degree (Master's or PhD) preferred.Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years ... role.Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly,… more
- Merck & Co. (Rahway, NJ)
- …robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Katalyst HealthCares and Life Sciences (Baltimore, MD)
- Responsibilities : Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed ... of products' registration. Participate on product development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical… 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 ... hospital-based products, software or electronic device products; Knowledge of regulatory submission requirements for FDA Class II medical devices, and… more
- Merck & Co. (Durham, NC)
- …Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination ... and compliance requirements governing development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU Medical Device … 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 ... Institute of Central Florida is looking for a qualified Device Technician - CVI Tavares & CVI The Villages...of Central Florida is seeking a skilled and detail-oriented Device Technician to join our team at our Tavares… more
- VB Spine LLC (Allendale, NJ)
- …a biomedical, scientific, or related technical discipline Minimum 1 year of experience in medical device labeling and/or regulatory affairs Understanding of ... Regulatory Labeling Specialist Location : Leesburg, VA or...to ensure labeling accuracy, usability, and alignment with global medical device regulations. Candidates should ideally be… more
- Foresight Diagnostics (Boulder, CO)
- …the ability to work collaboratively in a cross-functional environment. *Familiarity with medical device regulatory pathways and requirements. *Ability to ... to identify areas of non-compliance and recommend corrective actions. *Support medical device reporting, post-market surveillance, and vigilance reporting per… more
- Intuitive (Sunnyvale, CA)
- …Experience Minimum 3 years RA experience is required. Demonstrated understanding of NMPA medical device regulatory requirements, China GB/YY standards, Hong ... will play a key role in managing China RA regulatory intelligence, working closely with the in-country RA team...as well as fundamental US FDA requirements posed on medical device . Experience with new product development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk's Rare Disease portfolio. The Rare Disease portfolio includes medical treatments, customer solutions, and devices across multiple Therapy Areas ... driving customer impact by overseeing 5D efforts including Data, Diagnostics, Drug, Device , and Digital strategy and execution for relevant TAs, aligned closely with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Brand teams, other functional teams in NNI (including MAPA), including marketing, medical , R&D, regulatory affairs, finance, NNGlobal, and other relevant ... go-to-market plan for devices for the brand portfolio (eg, single dose device , PDS290, pre-filled syringe), and maintaining strategic oversight of device -related… more
- Synectics Inc (Dublin, CA)
- …Strong knowledge of regulatory requirements and quality standards for medical device manufacturing. Excellent project management and organizational skills. ... mechanical engineering background to join our team and oversee the transfer of medical device manufacturing processes from one facility to another, ensuring… more
- Eisai, Inc (Salt Lake City, UT)
- …with 3+ years experience in two or more of: infusion, diagnostic, biologic, medical device , buy and bill, rare disease, specialty pharmacy, and/or neurology; ... systems (including buy & bill, specialty pharmacy, distribution models, medical device and/or biologics experience) strongly preferred.Additional commercial… more
