- Beckman Coulter Diagnostics (Miami, FL)
- …and report to the Clinical Affairs Manager responsible for planning and executing IVD clinical trials. If you thrive in a cross-functional, detail-oriented role and ... required with 5+ years of clinical trial experience in vitro diagnostics ( IVD ), medical device, or healthcare clinical field.Demonstrated agility with processes and… more
- Cepheid (Miami, FL)
- …experience in Quality with a focus on assay development in a medical device or IVD l industry with applicable knowledge of FDA QSR, EU IVDR and other global ... regulations ISO 13485 and ISO 14971.Experience in implementing design control and risk management activities.Experience with technical data and capable of making risk-based recommendations, taking into account broad perspectives that support both the… more
- Hologic (Marlborough, MA)
- Manager, Regulatory Affairs ( IVD On-Market/Sustaining) San Diego, CA, United States Marlborough, MA, United States We are hiring in our Diagnostics Regulatory ... a minimum of 8-10 years direct experience in Regulatory Affairs within the IVD or medical device industries. + Master's Degree in biomedical engineering and/or RAC… more
- Nanobiosym, Inc. (Cambridge, MA)
- …or related field + Minimum of 7 years of relevant industry experience and IVD assay development + In depth knowledge and hands on experience with qPCR, sequencing ... and standard molecular biology techniques + Demonstrated technical, managerial and leadership expertise in assay development + Strong understanding of FDA and global regulatory requirements + Prefer commercial assay experience + Demonstrated experience and… more
- Danaher Corporation (Waltham, MA)
- …It would be a plus if you also possess previous experience in: + IVD and Proteomics Platforms + Working with US pharmaceutical, biotech, and leading academic ... customers + Selling complex solutions and services associated with traditional proteomics applications At Abcam we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles… more
- Danaher Corporation (Sunnyvale, CA)
- …+ Ability to travel up to 25%. It would be a plus if you also possess previous experience in: + Experience in life sciences industry + Knowledge of the infectious ... diseases' medical diagnostics domain Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …+ Provide QA/Engineering support as the quality representative on cross functional teams for new product development of reagents, assays and software, including ... software development lifecycle, SDLC. + Independently write, review, and approve technical documentation including plans, analytical and clinical protocols and reports. + Design control: Provide guidance to project managers on design documentation requirements… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …alignment with the drug global regulatory strategy and in compliance with the appropriate IVD regulations. You will need to work closely under the direction of the ... and beyond. + Maintain current understanding of changing global IVD and Companion Diagnostics (CDx) regulations, assess impact on...and EU IVDR). + Support preparation and filing of IVD Performance Study applications, SRD & IDE applications, HA… more
- Amgen (Washington, DC)
- …(CDx's). **Key responsibilities:** + Providing critical strategic and tactical IVD /CDx regulatory guidance that positively influences project planning and ... Providing regulatory leadership and input to internal teams involved with IVD /CDx development planning, including Diagnostic Development teams and joint project… more
- IDEX (Middleboro, MA)
- …or Engineering. Advanced degree is preferred. + 5+ years sales experience in IVD /Bio Instrument markets with a proven track record of consistent year-over-year sales ... Analytical Instrument experience is also acceptable. B2B sales experience in IVD /Bio Instrumentation markets is highly preferred. + Candidate must have excellent… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …This individual will be responsible for leading the regulatory support for IVD and CDx new product development, developing global regulatory strategies, submissions ... and interact with FDA to obtain clearance, preferably an IVD . + Demonstrated experience in authoring a IVDR Technical...Ability to interpret new regulations and understand and interpret IVD regulatory requirements. + RAC Certification is a plus.… more
- Fujifilm (Carson City, NV)
- …that community. As assigned interface with Senior Management teams from major IVD manufacturers. Maintain a comprehensive understanding of IVD reagent systems, ... with healthcare professionals and key opinion leaders for expansion of the IVD portfolio. + Display strong collaboration and teamwork skills with internal and… more
- Caris Life Sciences (Phoenix, AZ)
- …in the implementation of manufacturing operations in a hybrid (diagnostic/ IVD and clinical/CLIA/CAP/LDT) laboratory environment. **Job Responsibilities** + Process ... (Manufacturing) Operations. Support the creation of DMR and DHR for new medical device/ IVD products. + Risk Assessment: Partner with Risk Management team to conduct… more
- ThermoFisher Scientific (Middletown, VA)
- …The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the ... IVD industry for over 40 years. The division provides...of the world's largest suppliers of in vitro diagnostic ( IVD ) products rely on us as their OEM and… more
- ThermoFisher Scientific (Middletown, VA)
- …The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the ... IVD industry for over 40 years. The division provides...of the world's largest suppliers of in vitro diagnostic ( IVD ) products rely on us as their OEM and… more
- ThermoFisher Scientific (Middletown, VA)
- …The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the ... IVD industry for over 40 years. The division provides...of the world's largest suppliers of in vitro diagnostic ( IVD ) products rely on us as their OEM and… more
- Danaher Corporation (New York, NY)
- …or equivalent) + Industry Experience: Minimum 5 years in the biomedical or IVD industry, including Medical Affairs or Clinical affairs roles. + Clinical Expertise: ... insights into technology adoption strategies + Regulatory Knowledge: In-depth understanding of IVD and medical device regulations with strong familiarity of IVD … more
- ThermoFisher Scientific (Middletown, VA)
- …The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the ... IVD industry for over 40 years. The division provides...of the world's largest suppliers of in vitro diagnostic ( IVD ) products rely on us as their OEM and… more
- ThermoFisher Scientific (Middletown, VA)
- …Information:** The Clinical Diagnostics Division (CDD) offers diagnostic solutions for specific IVD market segments. It has a strong reputation and over 40 years ... of experience in the IVD industry. The division supplies products for drugs of...is trusted by major suppliers of in vitro diagnostic ( IVD ) products worldwide for OEM and contract manufacturing. We… more
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