- Abbott (St. Paul, MN)
- …in a broader enterprise/cross-division business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Fresenius Medical Center (Waltham, MA)
- …issues and broad design matters. + Understands and interprets US and international medical device regulatory requirements, provides guidance on requirements ... lines. Prepares regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets. Develops and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus. **Job Duties** + Facilitate ... **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device industry is mandatory. Minimum of 10 years with BS/BA, or 7… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …of five (5) years of Regulatory Affairs experience in the medical device industry required + Strong prioritizing, interpersonal, communication, and ... crucial role in supporting Medication Management Solutions (MMS) dispensing products, including non- medical devices , medical devices , associated… more
- Hologic (Marlborough, MA)
- …continuous improvement of regulatory compliance for our capital equipment medical device portfolio. Working cross-functionally with R&D, Quality, Clinical, ... submissions, license renewals, audits, and inspections for capital equipment medical devices + Review and update labeling,...5-8 years' regulatory affairs experience in the medical device industry, ideally with capital equipment… more
- US Tech Solutions (San Bruno, CA)
- …of Quality Concepts (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, Notified ... + Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring...and regulatory submissions. + Support bringing novel medical devices from concept to release, manage… more
- Abbott (Plymouth, MN)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- Kelly Services (Valencia, CA)
- …Burbank. If you have expertise in regulatory submissions and quality operations in the medical device sector, and are ready to take the next step in your ... Degree in Science. + 3-5 years of experience in biotech/ medical device /pharmaceutical regulatory affairs +.../pharmaceutical regulatory affairs + Knowledge of FDA medical devices and/or pharmaceutical (drug) registrations. +… more
- Bio-Techne (Austin, TX)
- …global regulatory strategies, ensuring compliance with FDA and international medical device regulations. Monitor industry trends, analyze regulatory ... manage workload independently. + Applied knowledge of FDA and international medical device regulations, global regulatory strategy, and submission processes.… more
- AbbVie (North Chicago, IL)
- …to the overall success of drug/ device development programs. Associate Director, Safety, Medical & Regulatory Quality is part of the R&D Quality Medical ... activities. The role covers AbbVie's entire portfolio of drug, device and cosmetics. The role ensures quality excellence through...Agency inspections. The role reports to the Director, Safety, Medical & Regulatory Quality. There is an… more