- Oracle (Olympia, WA)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Cardinal Health (Olympia, WA)
- …in related field or equivalent work experience, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**... and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory … more
- GRAIL (Olympia, WA)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals. + Effective… more
- Philips (Bothell, WA)
- …of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with Software as Medical ... As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal ...Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally. + You're able to work in… more
- Otsuka America Pharmaceutical Inc. (Olympia, WA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- ThermoFisher Scientific (Bothell, WA)
- …or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting and ... requirements and desired marketing claims. + Author and/or review regulatory submissions, specifically device master files, ...count on, which includes: + A choice of national medical and dental plans, and a national vision plan,… more
- Edwards Lifesciences (Seattle, WA)
- …the ground up. **How you'll make an impact:** + As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior ... Manager, Medical Affairs ) is responsible for providing scientific...across TMTT. The Senior Manager will be an experienced medical device professional with strong scientific acumen… more
- Fujifilm (Olympia, WA)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- Cardinal Health (Olympia, WA)
- …& Filing + Quality Review Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance ... provided expertise and guidance to help pharmaceutical, biotechnology and medical device companies get their products to...+ Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls… more
- Otsuka America Pharmaceutical Inc. (Olympia, WA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Philips (Bothell, WA)
- … Medical /Clinical Affairs or Medical Safety/ Medical Affairs Risk Management in Meical Device industry. Prior hands-on bedside/clinical experience ... ** Medical Safety Manager, Complaints Handling** The Medical...assessments on complaints related to harm to assist in regulatory reportability determination and serves as the primary clinical… more
- Edwards Lifesciences (Seattle, WA)
- …+ Knowledge of cardiovascular physiology and structural heart anatomy + Previous medical device Clinical Research experience in cardiology + Clinical research ... patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you… more
- GE HealthCare (Bellevue, WA)
- …management experience is preferred. + Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements ... Computer Science or equivalent. + Minimum 5 years' experience in Quality Assurance / Regulatory Affairs . + Minimum 3 years' experience in software within a… more
- Philips (Bothell, WA)
- ** Medical Education Program Specialist** You will be responsible for the development, facilitation, execution, documentation, and monitoring of our customer-facing ... Structural Heart Disease (SHD) medical training and educational programs as part of a...forecasting, while maintaining vendor relationships and financial compliance. Uphold regulatory standards and audit readiness for all educational activities,… more
- J&J Family of Companies (WA)
- …to identify growth opportunities and mitigate risks. + Collaborate with Marketing, Medical Affairs , Market Access, and other cross-functional teams to support ... Marketing, Access/Payer, Analytics or Business Development) within the pharmaceutical, biotech, medical device , or healthcare industry + Prior people management… more