- AbbVie (Irvine, CA)
- …equivalent to a PhD degree in a scientific field, plus 2 years' experience in regulatory affairs. + Experience in US medical devices regulatory affairs is ... documents, as well as technical reports, in support of regulatory submissions. + In-depth knowledge of US medical... regulatory submissions. + In-depth knowledge of US medical device regulations. + Ability to function in a… more
- AbbVie (Irvine, CA)
- …equivalent to a PhD degree in a scientific field, plus 4 years' experience in regulatory affairs. + Experience in US medical devices regulatory affairs is ... documents, as well as technical reports, in support of regulatory submissions. + Advanced knowledge of US medical... regulatory submissions. + Advanced knowledge of US medical device regulations. + Ability to function in a… more
- AbbVie (North Chicago, IL)
- …objectives, both strategic and applicable regulatory requirements. Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible for the ... management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA team which provides independent quality oversight of GxP activities,… more
- Amazon (Sunnyvale, CA)
- …part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products. The ... is to establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems; enabling...Devices and Services Medical Product Quality and Regulatory Systems; enabling the manufacture and distribution of safe,… more
- Robert Half Office Team (Norfolk, VA)
- …and completed at least 1 full 510(k) in the (not-too-distant) past. Requirements Medical - regulatory , Regulatory Agencies, Regulatory Documents, ... Regulatory Compliance, Regulatory Filings, Regulatory Policies, Regulatory Reporting, Regulatory Reporting Requirements, Regulatory Standards, … more
- Fresenius Medical Center (Waltham, MA)
- …Prepares regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets. Develops and maintains ... and broad design matters. + Understands and interprets US and international medical device regulatory requirements, provides guidance on requirements to product… more
- Abbott (Austin, TX)
- …and creativity in support of programs. **WHAT YOU'LL DO** + Develops sound global regulatory strategies for new and modified medical devices + Prepares robust ... education and experience + 8+ years technical experience + 6+ years medical device regulatory experience. Extensive experience with US and global medical … more
- Abbott (Pleasanton, CA)
- …+ Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus. + Experience with ... device regulations and submissions. + Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and… more
- Medtronic (Northridge, CA)
- …As Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... + Bachelor's degree and a minimum of 7 years of regulatory experience within the medical device, biotech, or pharmaceutical industries + Or advanced degree and… more
- Stryker (Allendale, NJ)
- …the Senior Staff Regulatory Affairs Specialist, you will work to maintain medical devices on the market and ensure ongoing compliance. You will participate on ... required, preferably with medical devices. + 5+ years of Medical Device Regulatory Affairs experience required. + Previous experience on EU MDR and drafting… more
- Abbott (Plano, TX)
- …in support of programs. **What You'll Work On** + Develops sound global regulatory strategies for new and modified medical devices. + Compiles, prepares, ... education and experience + 8+ years technical experience + 6+ years medical device regulatory experience. Extensive experience with US and global medical … more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …+ Flow cytometer experience a plus. + Premarket Experience: Experience supporting medical device regulatory submissions; proven experience with application of ... of possible** BD is one of the largest global medical technology companies in the world. Advancing the world...**Key responsibilities will include:** + Responsible for the global regulatory strategy for BDB products. + Coordinates and advises… more
- Sanofi Group (Swiftwater, PA)
- …phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and delivery ... risks are identified, communicated, and properly addressed. + Contribute to internal regulatory processes and procedures for medical devices and combination… more
- Medtronic (Mounds View, MN)
- …applicant profile. + Bachelor's degree required + Minimum of 7 years of experience in regulatory affairs in the medical device industry + Or minimum 5 years of ... medical device regulatory experience with an advanced degree Nice to Have (Preferred Qualifications): + Advanced degree in a scientific discipline (engineering,… more
- Stryker (Fremont, CA)
- …experience in an FDA regulated environment required + 5+ years' experience in medical device regulatory affairs required + RAC certification or Advance Degree ... to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory -affairs-team We are… more
- Stryker (Mahwah, NJ)
- … medical devices. + RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred. + Medical device regulatory experience preferred. ... to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory -affairs-team We are… more
- Teleflex (Wyomissing, PA)
- …a science or engineering field, or equivalent work experience. * 5+ years of Medical Device Regulatory Affairs experience, domestic and international. 3 years of ... Sr. Regulatory Affairs Specialist **Date:** May 28, 2024 **Location:**...:10403 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
- Medtronic (Mounds View, MN)
- …profile. + Bachelor's degree in a technical discipline + Minimum 4 Years of medical device regulatory experience with Bachelor's degree + Or minimum 2 Years ... Senior Regulatory Affairs Specialist - Cardiac Rhythm Management (hybrid)...of medical device regulatory experience with an advanced...of medical device regulatory experience with an advanced degree Nice To Have… more
- Stryker (Denver, CO)
- …Degree required; preferably in Engineering, Science, or related + 2+ years' medical device regulatory affairs experience required + Experience performing ... to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory -affairs-team We are… more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more