- 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
- 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 (Plymouth, 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
- Actalent (Irvine, CA)
- … Affairs Specialist II plays a pivotal role in ensuring that the company's medical devices comply with regulatory requirements throughout their lifecycle. ... accuracy, and linkage to training records where applicable. + Support regulatory submissions for medical devices . + Review design changes and provide tech… more
- Stryker (Redmond, WA)
- …Degree (Masters in Regulatory Affairs) + Previous experience with Class II/III medical devices + Experience authoring regulatory submissions for product ... Washington.** **What you will do** As part of the Medical Regulatory Affairs team, you will work...team, you will work with the team to maintain medical devices on the market and ensure… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …**Job Overview** The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies. ... years of experience in Regulatory Affairs working with complex medical device systems and software strongly preferred + Experience working with external… more
- Caldera Medical (Westlake Village, CA)
- …* Define and execute global regulatory strategies for Class I, II and III medical devices across all stages of the product lifecycle. * Lead the development ... related field. * 10+ years of progressive experience in regulatory affairs within the medical device...submissions and approvals for Class I, II and III devices . * In-depth knowledge of FDA, EU MDR/MDD, MDSAP,… more
Recent Jobs
-
Senior Business Analyst - Consumer Credit Risk Management - Forecasting & Reporting
- Capital One (Mclean, VA)
-
Data Entry
- Robert Half Office Team (Indianapolis, IN)
-
Transport RRT III
- Arkansas Children's (Little Rock, AR)
-
Echocardiographer Tech PRN
- HCA Healthcare (Reston, VA)