- Healgen Scientific Limited (Houston, TX)
- …journey! Healgen Scientific is a global leader in developing, manufacturing and commercializing In- Vitro Diagnostic test systems. Since our inception in 2007, we ... have strived to develop devices that meet and exceed industry standards. Our comprehensive portfolio of high quality, tailored solutions span multiple testing categories and analytes to meet various clinical and laboratory needs. Our products include rapid… more
- Kelly Services (Fremont, CA)
- …an experienced Labeling Specialist to create and revise labeling components for In Vitro Diagnostic (IVD) products and related documentation regulated by the FDA ... and ISO 13485. + This position requires a person who is detail-oriented, can manage multiple priorities, and has strong organizational skills. + The Labeling Specialist must be accustomed to working within established timelines and have a high attention to… more
- Actalent (Miami, FL)
- …a combination of clinical laboratory and either clinical research laboratory or in- vitro diagnostic / biotechnology / Pharmacology (FDA regulated) laboratory ... experience * MT or CLS (ASCP) or equivalent certification/license highly preferred * Prior R&D and/or clinical experience in urinalysis, hematology, immunoassay, clinical chemistry, or flow cytometry preferred Knowledge, Skills and Attitudes: * Strong verbal… more
- Actalent (South Portland, ME)
- …laboratory and technical writing experience working under design control and developing human in vitro diagnostic tests for commercialization in the US and OUS + ... Ability to work as part of a team with excellent communication skills + Problem-solving skills combined with analytical skills and attention to detail + Experience owning the end-to-end documentation creating process + Proficiency with Microsoft Office… more
- ICON Clinical Research (Farmingdale, NY)
- …As a Regulatory Affairs Manager you will need to be experienced with In Vitro Diagnostic (IVD) Medical Device regulation and Laboratory Developed Tests within ... the United States under FDA. This role will be collaborating with IVD product development teams in the context of early phase drug development, providing regulatory strategy, regulatory writing and submission, authority interactions, and regulatory operational… more
- Healgen Scientific Limited (Houston, TX)
- …journey! Healgen Scientific is a global leader in developing, manufacturing and commercializing In- Vitro Diagnostic test systems. Since our inception in 2007, we ... have strived to develop devices that meet and exceed industry standards. Our comprehensive portfolio of high quality, tailored solutions span multiple testing categories and analytes to meet various clinical and laboratory needs. Our products include rapid… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …connects everything we do. We pioneer, develop, and produce high quality in vitro diagnostic solutions that help healthcare professionals quickly and reliably ... determine a pathology or the source of a contamination and provide them with crucial information for optimal patient care. Be a part of the team that is responsible for deploying and sustaining the manufacturing of this life saving equipment. You will be… more
- Abbott (Atlanta, GA)
- …(or equivalent vocational qualifications) + Experienced in regulatory submissions for 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** + 5-7 years' experience in a regulated industry with a minimum of 3 of those years directly… more
- Abbott (Alameda, CA)
- …Solid knowledge of regulations and industry standards for medical device development and in vitro diagnostic device (IVD) including but not limited to ISO 13485, ... ISO 14971, and FDA Guidance for medical device development. + Experience in performing complex engineering calculations and relating results to design verification tests including statistical analysis and tolerance analysis + Working knowledge in writing… more
- Abbott (Pleasanton, 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** + Minimum of 5 years' experience working with Class II and/or Class III medical devices.… more