- Cedars-Sinai (Beverly Hills, CA)
- …Los Angeles and beyond. **Req ID** : 11799 **Working Title** : Lead Regulatory Coordinator - Medical Network **Department** : CA Heart Foundation **Business ... you ready to be a part of breakthrough research?** The Lead Regulatory Coordinator prepares and submits large and/or complex protocols and supporting documentation… more
- Hologic (Louisville, CO)
- Regulatory Affairs Specialist, Medical Device Louisville, CO, United States Marlborough, MA, United States **Join Hologic's Surgical Division as a ... **Experience** + 2-5 years in regulatory affairs, preferably within the medical device industry. + Proven experience preparing regulatory documentation… more
- Bausch Health (Bothell, WA)
- …Bachelors Degree Required Life science or technical discipline preferred. Minimum 6 years regulatory experiences in MNC medical device company (aesthetic ... device is a plus). Demonstrates profound knowledge and expertise in Active Medical Device international regulations, focus on US/Canada/MDR and APAC is a… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI)....medical or other technical fields and Class III medical device experience are preferred + Some… more
- Abbott (Santa Clara, CA)
- …and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) Program** to ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Maple Grove, MN)
- …managing projects related to harmonized regulatory activities in the Abbott's medical device division. As an individual contributor, the function of a ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....- Regulatory Review + EU and US medical device compliance + Project management skills… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …5 years of proven experience in regulatory affairs, ideally within the medical device or pharmaceutical industry. + Strong understanding of FDA regulations, ... Boards of Pharmacy (NABP) regulations. + Organize and validate device data for submission and registration with the FDA...state and international regulations related to medical devices . + Demonstrate ability to maintain regulatory … more
- Bausch Health (Bothell, WA)
- … required + Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… more
- Candela Corporation (Marlborough, MA)
- …RA topics required for both tactical and strategic initiatives. + Possess and exercise regulatory and medical device industry relationships to inform bold RA ... **Director, Global Regulatory Affairs** Requisition Number **2872** Location **US -...sciences/engineering/related field, plus 12 years of experience in the medical device industry with at least 10… more
- Hologic (Louisville, CO)
- …+ Bachelor's degree in a technical field preferred. + 2-5 years' experience in regulatory affairs ( medical device industry). + Experience with technical ... Regulatory Affairs Specialist, International Marlborough, MA, United States...Hologic, you'll play a vital role in bringing life-changing medical devices to market-both in the US… more
- 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