- 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
- GRAIL (Menlo Park, CA)
- …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 **Responsibilities:** + Strategize, plan, and author regulatory plans… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …related Regulatory and Regulatory Operations experience in medical devices and/or in vitro diagnostic field + Experience in Regulatory and Quality Information ... Management systems such as SAP, RIM, Veeva, Sharepoint or related systems + Working experience on creating dashboards and data analysis using tools like power BI. Knowledge and Skills + Working knowledge Regulatory Systems implementation + Ability to manage… more
- Bio-Techne (San Jose, CA)
- …Experience in biotechnology new product development for research use only (RUO) or in- vitro diagnostic (IVD) is required + Experience with biomolecule analytical ... separation and detection methods eg, HPLC, capillary electrophoresis (CZE, cIEF, CE-SDS), microfluidics is required + Must have demonstrated ability to develop commercial products of high degree of complexity + Strong track record of technical leadership,… 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)
- …+ Experienced in regulatory submissions for Pharmaceuticals, medical devices, and/or in vitro diagnostic 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. Regulatory Affairs… more
- ThermoFisher Scientific (Carlsbad, CA)
- …programs, as well as the development of Research Use Only (RUO) and In Vitro Diagnostic (IVD) software products and platforms. To be successful, this ... high-visibility position demands effective leadership over multiple tasks and teams, requiring a candidate with a collaborative approach, focus on deliverables, and excellent interpersonal skills. Moreover, this role requires a blend of proficiency in software… more
- Hologic (San Diego, CA)
- …+ Clean driver's license + Proficient knowledge of Medical Device Regulations, In Vitro Diagnostic Regulation, cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001 + ... Experience with PPAP (plus) **Skills:** + Expertise in various validation methods and evaluation criteria + Advanced understanding of process transfer, materials control, change control, manufacturing processes, and product testing + Proficient in interpreting… more
- Fujifilm (Sacramento, CA)
- **Position Overview** The Sales Specialist, Diagnostic Oncology, in the Invitro Diagnostics Division, is responsible for identifying, prioritizing, and establishing ... like you to help us get there. Our cutting-edge healthcare solutions span diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in-… more
- Fujifilm (Sacramento, CA)
- …like you to help us get there. Our cutting-edge healthcare solutions span diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in- ... vitro diagnostics. But we don't stop at healthcare; our...operating test equipment related to job (oscilloscope, meter, and diagnostic testers, etc.). + Valid driver's license and safe… more