- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …Bachelor's Degree required. Science background is preferred. Specialist: 3+ years in regulatory affairs, medical device /IVD industry required. 3+ years ... The Regulatory Affairs position within Regulatory Policy & Intelligence (RP&I) is responsible for contributing to or leading impact assessments and for changes… more
- Edwards Lifesciences (Irvine, CA)
- …clinical investigations, etc.). + Monitoring legal developments applicable to the Healthcare Regulatory and medical device spaces. + Other duties ... as needed.** **How you'll make an impact:** The Manager, Regulatory Counsel reports to the Senior Director, Regulatory...negotiating clinical trial agreements and associated contracts in the medical device or pharmaceutical industry or at… more
- Caldera Medical (Westlake Village, CA)
- …your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR,… more
- Abbott (Sylmar, CA)
- … fields. + 1+ year of Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of labeling, promotional, and or ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (St. Paul, MN)
- …+ Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices . + Experience of working within ... + Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements...years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification… more
- Abbott (Alameda, CA)
- … medical device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices , drugs and/or biologics including ... life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceuticals, medical devices , and/or… more
- Abbott (Alameda, CA)
- … medical device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....plus. . Experience with 510(k) applications, PMA supplements, US device regulations, and/ or with EU and other international… more
- Abbott (Alameda, CA)
- …a robust, scalable digital QMS tailored for Software as a Medical Device (SaMD) in a regulated environment. + Regulatory Strategy: Develop and execute ... Quality Assurance and Compliance system optimized for Software as Medical Device . In addition, this individual will...MDR/IVDR. + Successful track record of preparing and submitting regulatory dossiers for medical devices ,… more
- J&J Family of Companies (Irvine, CA)
- …in the medical device industry with at least four (4) years in Regulatory Affairs of Medical Devices . + Class III PMA experience is _preferred_ . ... 510K, and/or PMA submissions and EU Technical Document for medical devices for commercialization in the USA...._preferred_ . + Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations,… more
- J&J Family of Companies (Irvine, CA)
- …in the medical device industry with at least four (4) years in Regulatory Affairs of Medical Devices . + Class III PMA experience is **required** . ... 510K, and/or PMA submissions and EU Technical Document for medical devices for commercialization in the USA...._preferred_ . + Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations,… more