- ThermoFisher Scientific (South San Francisco, CA)
- …of Good Clinical Practices is required. + 4+ years working in the In Vitro Diagnostic or Medical Device Industry; companion Diagnostic experience is ... that the internal and external work performed to develop our in vitro diagnostics is in compliance with Good Clinical Practice, applicable regulatory requirements… more
- Sanofi Group (Morristown, NJ)
- …diverse team supporting the medical device, combination product, digital health and in- vitro diagnostic (IVD) products within the Sanofi portfolio of products. ... Diagnostic team you'll contribute to global regulatory strategies for in- vitro diagnostic technologies, collaborate with cross-functional teams to navigate… more
- GRAIL (Durham, NC)
- …GRAIL's quality management system (QMS). This role's focus is on the in vitro diagnostic medical device processes, supporting the clinical laboratory processes ... pharmaceutical, or biotech quality management system. + Experience working with in vitro diagnostic medical device regulations and standards including ISO… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …regulatory submissions to support the global commercialization of new or modified in vitro diagnostic (IVD) devices. The ideal candidate will have strong ... submissions to support the global commercialization of new or modified in vitro diagnostic (IVD) devices as well as research use only (RUO) products. The… more
- Abbott (Pomona, CA)
- …will lead cross-functional teams in the development and commercialization of In Vitro Diagnostic (IVD) products within Abbott's Toxicology business unit. This ... a team player who possess effective communication + Hands-on experience with in- vitro diagnostic + Medical device development and product commercialization… more
- Abbott (Alameda, CA)
- …vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices. + Experience of ... Device Regulation (MDR - Regulation (EU) 2017/745) and/or the In Vitro Diagnostic Medical Device Regulation (IVDR - Regulation (EU) 2017/746) + Experience… more
- Sanofi Group (Morristown, NJ)
- …diverse team supporting the medical device, combination product, digital health and in- vitro diagnostic (IVD) products within the Sanofi portfolio of products. ... GRA Device Lead in the GRA Device Digital and Diagnostic team you'll drive global regulatory strategies for medical...enhanced through our diverse portfolio of medical device and diagnostic products. Together, we chase the miracles of science… more
- Danaher Corporation (Bothell, WA)
- …of synthetic oligonucleotides under a cGMP environment for use in Cepheid in- vitro diagnostic products. The Laboratory Technician will use scientific knowledge ... 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 (Rockville, MD)
- …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
- Grifols Shared Services North America, Inc (San Diego, CA)
- …for ensuring regulatory compliance and supporting global market access for in vitro diagnostic (IVD) products. It involves developing and executing regulatory ... medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions in San Diego, CA is seeking a Regulatory Affairs Specialist… more
- Roche (Tucson, AZ)
- …Launch Decision. + You will provide strategic insight into worldwide in vitro diagnostic and pharmaceutical markets, including product development strategies, ... product changes in a regulated environment and have an understanding of Diagnostic Design Control processes. **Travel Requirements:** + Based on business needs.… more
- Caris Life Sciences (Tempe, AZ)
- …a key contributor in the Translational Science team responsible for supporting companion diagnostic and in vitro diagnostic product development lifecycle ... strategies to support global marketing authorizations. This includes clinical programs with focused attention on Design Controls and Good Clinical Practices for clinical performance studies. The Global Companion Diagnostics Specialist will collaborate with… more
- ThermoFisher Scientific (Wilmington, NC)
- …and training, and capable of motivating and integrating teams + Strong In Vitro Diagnostic Devices Regulations (IVDR), and ISO20916 + Strong planning and ... organizational skills to enable effective prioritization of workload and workload of team members + Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization + Solid understanding of change management principles +… more
- Actalent (Rockville, MD)
- …Supervisory experience is a plus. + Experience in manufacturing immunoassays, reagents, in- vitro diagnostic devices, and biotech consumables is desirable. + ... Familiarity with manufacturing techniques such as roll-to-roll processing, plastic film and metal foil processing techniques, and coating techniques. Work Environment Work in an office environment with opportunities for hands-on experimental work. The company… more
- Abbott (Pomona, CA)
- …of Quality Assurance in a medical device manufacturing environment, preferably in- vitro diagnostic . + Experience implementing various product and process ... improvement methodologies (eg, Six Sigma and Lean Manufacturing). + Advanced skills including statistical/data analysis and report writing skills. + Prior medical device experience preferred. + Knowledge of Quality System Regulations. **COMPETENCIES:** +… more
- GRAIL (Albany, NY)
- …This individual monitors and communicates changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership. They ... may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned with GRAIL's values You are approved to work remotely. While your primary workplace is… more
- Hologic (San Diego, CA)
- …FDA 21 CFR 820, ISO 13485 as well as CE mark requirements, In Vitro Diagnostic Regulation (EU) 2017/746 and Medical Device Regulation (EU) 2017/745, Risk ... Management ISO 14971, and other applicable quality and regulatory standards. + Extensive experience and understanding of design, development, verification, and validation processes. + Strong knowledge of scientific principles and concepts. **So why join… more
- Abbott (Alameda, CA)
- …vocational qualifications) . Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices. . Experience of ... working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). Preferred Qualifications . 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs.… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …5 years of strong Regulatory Affairs experience in the medical device and/or in vitro diagnostic and/or regulated product field + Project Management experience + ... Sound understanding of design control processes, FDA, and global regulations and standards + Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information + Excellent interpersonal, communication and analytical skills +… more
- Danaher Corporation (Waltham, MA)
- …plus if you also possess previous experience in: + Experience with In Vitro Diagnostic medical devices + Experience with Immunohistochemistry methods and ... evaluation #LI-GC1 Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring… more
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