- Abbott (Alameda, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... R&D, System Engineering, Product Quality, Technical Quality, CAPA, and Regulatory Affairs . **What You'll Work On** +...Quality responsibilities as they apply to the develop of medical device software, as well as the… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …have as well as a demonstrated knowledge of drug/ device combination and medical device products and their regulatory pathways. + Demonstrated Quality ... Collaborates with other external functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC function is adequately represented… more
- Astrix Technology (Boston, MA)
- …Work closely with internal teams such as Clinical Development, Regulatory Affairs , and Commercial to provide medical insights that inform strategic ... medical affairs role within the pharmaceutical, biotechnology, or medical device industry. + Scientific Expertise: Deep understanding of therapeutic… more
- Abbott (Santa Clara, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... can grow the career you dream of. + Free medical coverage for employees* via the Health Investment Plan...other departments including Global Clinical Operations, Research & Development, Regulatory Affairs , and Biostatistics. + Writes, study… more
- Actalent (Irvine, CA)
- …to lead Quality Assurance (QA) activities for a strategic M&A initiative in the medical device industry. This role demands a strong leader capable of navigating ... complex situations and collaborating effectively with cross-functional teams, including Regulatory Affairs (RA) and Clinical Affairs (CA). . Responsibilities… more
- J&J Family of Companies (Irvine, CA)
- …Organizations (CRO), and vendors, and with internal teams: medical affairs , data management, biostatistics, data programmers, and regulatory affairs ... content that communicates clinical and real-world data on the Company's Electrophysiology medical devices . This role is responsible for contributing scientific… more
- J&J Family of Companies (Irvine, CA)
- …in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio ... Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the Scientific Operations...regulated environment including 3 years of direct experience with medical devices in the fields of technical… more
- GE HealthCare (Bellevue, WA)
- …management experience is preferred. + Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements ... design and development of software products to support both medical and non- medical devices . This...+ Minimum 5 years' experience in Quality Assurance / Regulatory Affairs . + Minimum 3 years' experience… more
- Olympus Corporation of the Americas (Center Valley, PA)
- … products to ensure products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and for supporting business ... Duties** + Supports supplier quality activities for sourced finished Medical Device products and leads these supplier...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Stryker (Sacramento, CA)
- …clinical data. + Form and justify conclusions regarding the overall benefit-risk profile of medical devices , in collaboration with a medical expert and other ... + years of industry experience in clinical, quality, or regulatory affairs (risk management, design quality, post-market...3 years of experience in writing clinical evaluations for medical devices required. + Demonstrated ability to… more