- Amgen (Washington, DC)
- …a breadth of technical expertise across a broad range of in- vitro diagnostic technologies, influencing decision-making through negotiation, and addressing ... companion diagnostics development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple markets preferred + Knowledge… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …team in further launch activities. The ideal candidate will have medical device and in vitro diagnostic experience in the US and EU, as well as experience with ... Minimum 5 years Regulatory Affairs experience in medical device or in vitro diagnostic device companies or an equivalent combination of experience with an… more
- Danaher Corporation (West Sacramento, CA)
- …part of a multifunctional team and drive to root cause for manufacturing of in- vitro diagnostic consumables. + Lead projects to assess risk (pFMEAs), perform ... validations (equipment, process, software), and implement process changes for manufacturing of in- vitro diagnostic consumables. + Lead or participate in cross… more
- Danaher Corporation (Bothell, WA)
- …and completion of Operations programs within a medical device and/or molecular in- vitro diagnostic company while ensuring consistency with company strategy, ... or DBS certification is highly preferred + Medical device and/or In Vitro Diagnostic product experience + Business Solutions implementation experience Cepheid,… more
- Danaher Corporation (Sunnyvale, CA)
- …and completion of Operations programs within a medical device and/or molecular in- vitro diagnostic company while ensuring consistency with company strategy, ... or DBS certification is highly preferred. + Medical device and/or In Vitro Diagnostic product experience. + Business solutions implementation experience.… more
- Bristol Myers Squibb (Cambridge, MA)
- …Experience with or good working knowledge of a broad range of biomarker/in vitro diagnostic platforms. Demonstrated matrix leadership skills and the ability to ... Medicine Search, Evaluation, and Alliances is responsible for leading strategic diagnostic initiatives that support BMS's Precision Medicine strategy. This includes… more
- Kelly Services (South San Francisco, CA)
- …position is focused on pre-market development activities with a key focus on in vitro diagnostic systems including assay, software and hardware. This role also ... + Solid working knowledge of global regulatory requirements related to in- vitro diagnostics systems, laboratory automation and software / hardware components of… more
- Danaher Corporation (Sunnyvale, CA)
- …compliance with Food & Drug Administration (FDA), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory ... are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of...Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges,… more
- Danaher Corporation (Sunnyvale, CA)
- …and/or Human Physiology with related work experience. + Experience with in vitro diagnostic (IVD) products, preferably in molecular diagnostics or ... are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of...Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges,… more
- ThermoFisher Scientific (Indianapolis, IN)
- …ISO 13485) preferred. + Working knowledge of FDA regulations and IVDR (In Vitro Diagnostic Regulation) requirements is highly preferred. + Familiarity with HLA ... a growing software organization, you will work at the intersection of diagnostic precision, digital health, and lab workflow transformation. You will contribute to… more
- Abbott (Santa Clara, CA)
- …vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices. + Experience of ... Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/ diagnostic context in order to assess regulatory implications for… more
- ThermoFisher Scientific (Middletown, VA)
- …that are manufactured on an OEM basis for the global leaders of the in vitro diagnostic industry. **Position summary** In this role, you will be the primary ... manufacturing process and routine supply for a wide range of diagnostic reagents across multiple areas including immunoassay, clinical chemistry, hematology and… more
- ThermoFisher Scientific (Middletown, VA)
- …part of the Middletown, VA team, some of the world's largest suppliers of in vitro diagnostic (IVD) products rely on us as their OEM and contract manufacturing ... Specific Information:** The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been… more
- Danaher Corporation (Sunnyvale, CA)
- …compliance with Food & Drug Administration (FDA), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory ... At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make… more
- ThermoFisher Scientific (Middletown, VA)
- …part of the Middletown, VA team, some of the world's largest suppliers of in vitro diagnostic (IVD) products rely on us as their OEM and contract manufacturing ... Specific Information:** The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been… more
- Avania (Boston, MA)
- …and execution of product market access strategies in the medical device and in vitro diagnostic sectors. In the key role of Senior Associate, you will ... launch strategies for the latest, leading-edge innovations in medical devices and diagnostic products. You will work with both start-ups and major manufacturers… more
- ThermoFisher Scientific (Middletown, VA)
- …part of the Middletown, VA team, some of the world's largest suppliers of in vitro diagnostic (IVD) products rely on us as their OEM and contract manufacturing ... Specific Information** The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been… more
- Danaher Corporation (Richmond, IL)
- …Biosystems is responsible for working with cross-functional teams to bring IVD (In- Vitro Diagnostic ), Research (RUO) and Laboratorial products to market and ... knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of… more
- Caris Life Sciences (Phoenix, AZ)
- …as a leader of the product marketing function. Prior healthcare experience (in vitro diagnostic , pharmaceutical, oncology, etc.) a plus. + Product Upstream ... Marketing for an oncologist/patient-facing physician audience in biotech, medical device, or similar industry required + Must have experience: launching and supporting existing products, leading a product marketing team, owning and driving product and product… more
- Actalent (San Diego, CA)
- …Summary: Responsible for overseeing the labeling process for both new and existing in vitro diagnostic (IVD) and medical device (MD) products. This role requires ... cross-functional collaboration to ensure labeling deliverables meet regulatory, design, and operational standards. Key Responsibilities: + Manage the development and revision of product labeling, including manuals, Instructions for Use (IFUs), packaging, and… more
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