- Merck & Co. (Rahway, NJ)
- …Manufacturing Compliance, Medical Devices , Product Commercialization, Quality Management System Improvement, Regulatory Compliance, Regulatory ... managing external partners in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on… more
- Merck & Co. (Rahway, NJ)
- …Fast-Paced Environments, Geometric Dimensioning And Tolerancing (GD&T), ISO 13485 Medical Devices , Manufacturing Processes, Mechanical Design, Mechanical ... 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
- Merck & Co. (Rahway, NJ)
- …Human Factor Engineering, Inventory Control System, Inventory Management, Mechanical Testing, Medical Device Quality Systems, Negotiation, Project ... plans and benefits DD&T lab operations.Collaborate across DD&T sub-functions, regulatory affairs, quality assurance, Pharmaceutical Operations, Analytical R&D,… 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
- Merck & Co. (Rahway, NJ)
- …regulatory requirements such as ISO, USP, FDA guidelines, and other global regulatory standards pertaining to medical devices and combination ... and support of Autoinjectors. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, manufacturing, and … more
- Aequor (Irvine, CA)
- …for medical devices (eg MDRs, Vigilance reports, etc.) Familiarity with medical device complaint files and quality records Knowledgeable of FDA ... external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices Minimum Requirements:… more
- Merck & Co. (Rahway, NJ)
- …new product packaging development for vaccine and biologic dosage form products, including Medical Device and Combination Products (MDCPs) in the human health ... understanding and experience of unique requirements of packaging system development of Medical Device and Combination Products, including pre-filled syringes and… 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 ... & device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful candidate will… 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 ... sites, device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful candidate will… more
- Merck & Co. (North Wales, PA)
- …support-complex technical projects and/or equipment technology assessments within the packaging and Medical Devices & Combination Products (MDCP) space as part ... and Qualifications: Minimum of 10 years' experience in the pharmaceutical, biotechnology, or medical device industry, with at least 3-5 years in a leadership… 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. (Rahway, NJ)
- …requirements for CMC. Strong understanding of integration and partnering with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... Process Development, Process Scale Up, Professional Collaboration, Professional Networking, Quality by Design, Regulatory Filings, Social Collaboration {+… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications - Data 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
- 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)
- …in 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...studies are conducted according to the timeline, budget and quality measures set forth by the Study teams. This… 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
- Merck & Co. (Rahway, NJ)
- …transportation technologies for pharmaceutical products including parenteral and/or medical device and combination products.Demonstrated experience in ... and maintain strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the ... equipment and takes actions to optimize the output, reliability, quality , performance. He/she makes proposals for Continuous improvement and...departments. You will also look for new technologies / devices to optimize the process. You are in close… more
- Repligen (Rancho Dominguez, CA)
- …due to safety and regulatory requirements.Minimum of 1-2 years of experience in medical device assembly.Proficient in the use of hand tools, power tools, and ... be assigned to various functions as needed to ensure the delivery of high- quality products to our customers on time.ResponsibilitiesAdhere to and complete tasks as… more
- Repligen (Clifton Park, NY)
- …certification.Experience in regulated or high-mix manufacturing environments (eg, medical devices , biopharma, aerospace, automotive).ERP/MES familiarity.Desire ... plastics injection molding facility, ensuring compliance with cGMP, EHS, and regulatory requirements. This role combines production leadership with RPS (Repligen… more
