- 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
- Merck & Co. (Rahway, NJ)
- … Device Design Control, Medical Device Management, Medical Device Regulations, Medical Devices , Medical Devices Design, Medical ... development including regulatory submission and approval processes. Including development drug- device combination product or a medical device component… 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
- 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
- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- …, and Medical Device Directive (93/42/EEC) and Medical Device Regulation (EU 2017/745) CE Mark compliant Quality Management System. Manages and ... years of relevant experience in GMP, medical devices , or pharmaceuticals, preferably within a Regulatory -related...and in Valencia. Experience with compliance to MDSAP, European Medical Device Directives (MDD), EU MDR/IVD, FDA,… more
- Merck & Co. (Rahway, NJ)
- …risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... Leading International Teams, Management Process, Manufacturing Scale-Up, Medical Device Regulations, Medical Devices , Packaging Engineering, Packaging… more
- Merck & Co. (Durham, NC)
- …Standards, GMP Compliance, Immunochemistry, Internal Auditing, IS Audit, Management Process, Medical Devices , Molecular Microbiology, Quality Auditing, ... in one or more of the following areas, based on site activities; Medical Device /Combination products, Biologics, Vaccines, API's or Non Sterile or Sterile… more
- Novo Nordisk Inc. (Minneapolis, MN)
- 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 (Jaffrey, NH)
- …in extrusion, preferably medical -grade tubing. 0-3 years' experience in a medical device or other regulated manufacturing environment. Ability to lift 50 ... maintaining polymer extrusion lines used in the production of complex and custom medical -grade tubing for both production and R&D purposes. This role is critical to… more
- MCKESSON (Richmond, VA)
- …device servicing business. The ideal candidate will bring a strong background in quality systems, medical device or pharmaceutical regulations, and team ... Prepare and present periodic reports to senior leadership and regulatory bodies. Maintain and improve quality system...least 7 years in a leadership role. Experience in medical device , pharmaceutical, or combination product industries.… more
- Fresenius Medical Care (Albany, OR)
- …DUTIES AND RESPONSIBILITIES: QUALITY : Responsible for supporting and driving quality standards through meeting regulatory requirements and the practice of ... equipment and technology, including but not limited, patient monitors, defibrillators, medical recording devices and computers. Ensures the inspection of… 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
- Ochsner Health System (Laplace, LA)
- …to ensure images meet diagnostic quality standards. * Completes timely quality control procedures in accordance with regulatory standards and performing ... current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area...the amount of force exerted is negligible. Mechanical lifting devices (carts, dollies, etc.) or team lifts should be… more
- Ochsner Health System (Metairie, LA)
- …to ensure images meet diagnostic quality standards. * Completes timely quality control procedures in accordance with regulatory standards and performing ... current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area...the amount of force exerted is negligible. Mechanical lifting devices (carts, dollies, etc.) or team lifts should be… 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
- Merck & Co. (Rahway, NJ)
- …transportation technologies for pharmaceutical products including parenteral and/or medical device and combination products. Demonstrated experience ... and maintain strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to… more
Related Job Searches:
Devices,
Medical,
Medical Devices,
Medical Regulatory,
Quality,
Quality Regulatory,
Regulatory,
Regulatory Medical Devices