- Merck & Co. (Rahway, NJ)
- …materials to foster a culture of operational excellence Ensure processes align with regulatory requirements for medical device and drug combination products ... processes related to device -drug integration. Partner with Quality and Regulatory teams to ensure compliance... devices Knowledge of US and global combination product/ medical device and healthcare regulations, including FDA… more
- Aptyx (Charlotte, NC)
- Position Overview We are seeking a Medical Device Engineer with strong experience in the design and development of complex steerable catheters. This role is ... engineering, or a related field. Three or more years of experience in interventional medical device development, with preference for at least five years of… more
- Merck & Co. (Rahway, NJ)
- … Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management activities, ... Minimum of 6 years of experience in pharmaceutical development, device development, device systems operations, quality... management, or a related area. Strong knowledge of regulatory requirements and industry standards related to device… more
- Aptyx (Charlotte, NC)
- …Strong understanding of materials science principles related to fluoropolymers. Experience in medical device development within an ISO 13485 environment. Ability ... are seeking an engineer with growing to advanced expertise in expanded PTFE devices . This role supports and leads product development efforts for components that… more
- Aptyx (Charlotte, NC)
- …applicable Aptyx SOP's included in the Training Matrix. Manage projects for disposable medical devices from concept to production. Communicate to the customer ... or other certificated preferred Experience 3+ years experience in engineering for medical devices Experience with concept to commercialization is preferred… more
- Twist BioScience (South San Francisco, CA)
- …GMP, Biotechnology, Pharmaceuticals or another Regulated Industry.Experience in Quality Assurance/ Regulatory requirements in medical devices , IVD, EU ... interact with individuals at multiple levels within all functional departments, including Quality Assurance, Regulatory Affairs, Supplier Quality , Supply… more
- Bayer (Saxonburg, PA)
- …following: REQUIRED QUALIFICATIONS Bachelor's Degree in Engineering; Experience using relevant quality , supplier management or medical device manufacturing ... for visiting assigned suppliers, as needed, to ensure all quality controls are in place and all regulatory...and potentially abroad. PREFERRED QUALIFICATIONS 4-7 years using relevant quality , supplier management or medical device… more
- Novo Nordisk Inc. (Seattle, WA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Novo Nordisk Inc. (New Orleans, LA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Aptyx (Taunton, MA)
- …a controlled quality system (eg, ISO 9001 and/or ISO 13485); medical device manufacturing experience preferred. Experience with melt extrusion processes ... provides technical support to Aptyx's extrusion manufacturing operations within commercial and medical device environments. This role is responsible for setting… more
- Syner-G BioPharma Group (Boston, MA)
- …Experience: 4-7 years of experience within the biotech, pharmaceutical, or medical device industry.Knowledge and experience working with FDA cGMP, ... We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients… more
- Merck & Co. (Rahway, NJ)
- …:- Demonstrated expertise of technical aspects and interdependencies across DS, DP, Device , Packaging, and Analytical, Regulatory , Quality , and Supply ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …includes clinical or basic research in a pharmaceutical company, a Medical device /Diagnostic company, Academic Research Organization (ARO), hospital/ medical ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...agreed quality standards and timelines and that quality of data is suitable for regulatory … more
- Insmed Incorporated (NJ)
- …will be a strategic leader, ensuring that development programs meet scientific, quality , regulatory , and commercial standards, while ensuring execution across ... collaboration will be vital as you partner with Discovery, Clinical Development, Quality , Regulatory Affairs, Operations, and Commercial teams to ensure seamless… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …degree or higherA minimum of two (2) years related experience in medical device , biopharmaceutical, or pharmaceutical industryA degree in Biology, Biochemistry, ... Microbiology, Chemistry or related fieldSolid understanding of regulatory requirements, policies and guidelinesExperience with Quality ...and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a… more
- Aptyx (Taunton, MA)
- …of experience in a manufacturing environment, preferably in a regulated or medical device setting. Demonstrated technical knowledge of manufacturing processes, ... a manufacturing environment. Experience working within ISO 13485 and/or ISO 9001 quality systems. Experience with extrusion processes, medical tubing, or similar… more
- Aequor (Aliquippa, PA)
- …inbound/outbound coordination, and ERP transaction execution-preferably within GMP, biotech, medical device , or other regulated environments. They are ... tracker solution to provide real-time visibility of receipt lifecycle status and quality workflow stages. Develop, maintain, and monitor incoming purchase orders and… more
- Merck & Co. (Rahway, NJ)
- …of experience in an Automation or Engineering function for Biologics, Food, Medical Devices , or Pharmaceutical industries-Proven experience with development and ... for all GxP automation systems.Lead integration of control systems with MES, Quality , and Batch Reporting applications.Understand and adhere to CFR, GMP, and data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …lift and manlifts, and hand and power tools.Repair of instrumentation, electrical devices , circuits, and switchgear used in cGMP and non GMP systems. Investigate, ... thermal energy principals, mechanical maintenance techniques, and electromechanical theory.Ensures regulatory and job training remains current by promptly completing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support the optimization and efficient utilization of the warehouse space.Assist in regulatory inspections, perform safety and quality audits, and answer ... to 20/30 (Snellen) or better with corrective lenses.Using Audiometric Devices : No average hearing loss in the better ear...and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a… more
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