- Fujifilm (Sacramento, CA)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...other applicable laws. + Keep abreast of legislative and regulatory changes with respect to healthcare and other relevant… 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 (Santa Clara, CA)
- …providing strategic and predictable Regulatory Services in collaboration with the medical device business units that Leveraged Services team supports. **The ... on regulatory activities and works with the medical device business units that Leverage Services...and leadership experience to support the medical device business units with their regulatory submissions.… 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 mentoring to engineers to ensure audit readiness and regulatory submissions. + Support bringing novel medical … more
- Kelly Services (Oakland, CA)
- …related experience, or PhD + 5 years of related experience . 6-8 years of regulatory experience in a medical device and/or diagnostics company involved with ... **Kelly(R) Science & Clinical** is seeking a Sr. Regulatory Affairs Manager for a contract-to-hire position at a cutting-edge client in Seattle, WA . If you're… more
- Gilead Sciences, Inc. (La Verne, CA)
- … reports (MDRs) and provide documented justifications for reportable and non‑reportable regulatory decisions. + Support medical device and combination ... provides comprehensive support of these combination products. **Roles/Responsibilities:** + Monitor medical device standards for quality management system (QMS)… more
- Abbott (Santa Clara, CA)
- …in a broader enterprise/cross-division business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- GRAIL (Menlo Park, CA)
- …clinical affairs, quality, or program management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device ... US and international regulatory frameworks and processes for medical device development and approvals. + Effective collaborator in dynamic, fast-paced, and… more
- Actalent (San Diego, CA)
- …of new and revised labeling materials. Required Skills & Experience: + Experience in medical device labeling and regulatory compliance. + Proficiency in ... the labeling process for both new and existing In Vitro Diagnostic (IVD) and Medical Device (MD) products. This role requires cross-functional coordination and a… 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 ... of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist, you will play a crucial role...existing US and international regulations and directives (eg, FDA Medical Device Regulations, EU Low Voltage Directive,… more