- 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 (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
- 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
- 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
- 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
- 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
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …10 years of directly related Regulatory Affairs experience in medical devices and/or in vitro diagnostic field + Minimum of 7 years of personnel management ... (direct report) experience including performance evaluations/improvement, and career development + Software experience including SaMD/SiMD is a plus + Regulatory and Quality Information Management systems such as SAP, RIM, or related systems + Digital literacy… more
- Abbott (Alameda, CA)
- …action of medical devices, including software as a medical device (SaMD), in- vitro , diagnostic devices, consumer devices, and accessories. **What You'll Work ... On** + Lead/support design planning efforts to include heading cross-functional teams; establishing deliverables and tracking completion for complex projects + Lead/support complex investigations and CAPA activities + Drives alignment in cross functional… more