- GRAIL (Concord, NH)
- …years of experience in regulatory, development, clinical affairs, quality, or program management within the IVD , medical device, or pharmaceutical industries. + ... Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market product … more
- Danaher Corporation (West Sacramento, CA)
- …Learn about the Danaher Business System which makes everything possible. The Senior Director , Marketing and Product Management - Microbiology for Beckman ... organization-read on. In this role, you will have the opportunity to: + Lead Product Portfolio Strategy & Lifecycle Management : Drive product portfolio… more
- Sanofi Group (Morristown, NJ)
- …Device team is a globally diverse team supporting the medical device, combination product , digital health and in-vitro diagnostic ( IVD ) products within the ... management activities for device submissions/device aspects of medicinal product submissions + Liaises with device, clinical, manufacturing, commercial, and… more
- Hologic (San Diego, CA)
- Director , Clinical Science San Diego, CA, United States...for global new product development initiatives and product life cycle management . + Leads a ... leader where you'll drive innovative clinical evidence development and execution for new product development. In this influential role, you will lead a team of six… more
- Abbott (San Diego, CA)
- …to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The Director , AI, Algorithms ... to advance our AI strategy to significantly enhance resource efficiency, streamlining product development processes, and elevate the overall quality of products and… more
- Bristol Myers Squibb (Princeton, NJ)
- …partnership with the Precision Medicine Lead + Provide regulatory support on product partnership, vendor management and business development opportunities + ... personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory… more
- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Regulatory Affairs Diagnostics. This position is a hybrid role and ... application. We invite candidates from any location to apply. The Associate Director , Global Regulatory Affairs Diagnostics will provide an opportunity to work in… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …fostering collaboration, improving performance, and ensuring consistent application of project management and product development processes." + Provide direct ... and may indicate a preference during the interview process. The Program Management function is accountable for providing expertise, support, and control for programs… more
- Bio-Techne (Minneapolis, MN)
- …worldwide.** Pay Range: $153,300.00 - $251,850.00 **Position Summary:** The Director of Manufacturing is responsible for overseeing and optimizing manufacturing ... for leading and executing strategies to meet the demand of our high-mix product lines, including ELISA kits, Luminex assays, and other protein analysis product… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …: Collaborate closely with cross-functional teams, including software development, product management , quality assurance, and regulatory affairs, to ... of innovative diagnostic solutions. We are seeking a visionary and experienced Director of Software Test to lead our global software testing organization. This… more
- AbbVie (North Chicago, IL)
- …for proactive safety strategy, medical safety assessment of SAE/AEs reported to Product Surveillance, clinical study safety management , contribution to post ... Risk Benefit Analysis, Design & process FMEAs, and Risk Management Reports + Participates in Health Product ...for Use (IFU) to ensure accurate device labeling New Product (Device, Combo, IVD ) Development Participates as… more
- Danaher Corporation (Chaska, MN)
- …responsible for Immunoassay and Reagent Solutions. This position reports to the Senior Director , Product Management , within the Clinical Chemistry & ... at a Time. In this role, you will have the opportunity to: + Lead product lifecycle management for immunoassays, ensuring alignment with business unit goals and… more
- Bristol Myers Squibb (Princeton, NJ)
- …CLIA, CAP, ISO13485, and ICH-GCP standards while driving Design Verification, Validation, Product Risk Management , and Traceability Matrix execution. This is a ... CLIA, CAP, IVDR, ISO13485, and ICH-GCP. + Expertise in Design Verification, Validation, Product Risk Management , and Traceability Matrices. + Skilled in IHC… more
- Danaher Corporation (West Sacramento, CA)
- … of Global Commercial Marketing- Microbiology and is part of the Global Marketing and Product Management Team located in West Sacramento, CA and will be an ... complex projects, balancing priorities and aligning internal stakeholders (marketing, sales, product management ) with external customer expectations. + Capture… more
- Danaher Corporation (Waltham, MA)
- …leadership by leveraging market intelligence, advanced knowledge of the Abcam product and services portfolio, and collaboration with stakeholders. You will manage ... new business opportunities with named Strategic Partners. This position reports to the Director of Strategic Partnerships as a part of the Strategy and Partnerships… more
- Evident Scientific (Needham, MA)
- …Clinical Affairs and RA with focus on Clinical Affairs and Clinical Trial management for Medical Devices/ IVD . + Hands-on experience with FDA 510(k)/PMA ... submissions, inspections, and QMS compliance activities. Reporting to the Global Director of Regulatory Affairs - Clinical Business, the incumbent ensures scientific… more