- Abbott (Alameda, CA)
- … medical device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....plus. . Experience with 510(k) applications, PMA supplements, US device regulations, and/ or with EU and other international… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …knowledge of risk management processes (ISO 14971) and cybersecurity considerations for medical devices . + Exceptional analytical and problem-solving skills. + ... The role involves developing and implementing practices for SaMD devices to ensure regulatory compliance, expedition of...compliance with FDA's guidance on device versus non- device functionality. + Prepare, submit, and manage regulatory… more
- Oura (San Francisco, CA)
- …health products, including wearable devices and related software, including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), ... and Good Manufacturing Practices (GMPs), as well as post-market compliance, including Medical Device Reporting (MDR), product recalls, corrective actions, and… 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
- Abbott (Santa Clara, CA)
- …+ Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices . + Experience of working within ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- GRAIL (Menlo Park, CA)
- …, development, clinical affairs, quality , or program management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and ... knowledge of US and international regulatory frameworks and processes for medical device development and approvals. + Effective collaborator in dynamic,… more
- J&J Family of Companies (Santa Clara, CA)
- …Specialist is an individual contributor who will help secure and retain global regulatory approvals for medical devices by archiving, creating, and ... worldwide regulatory submissions in compliance with geography-specific regulatory requirements + Support verification and quality ...0 - 1 years' experience in medical device , life science, pharma industry Experience in regulatory… more
- Abbott (Sylmar, CA)
- …(eg, medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… 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 ... balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory ...in a timely manner. + Experience working in the Medical Device industry. + Certification is a… more
- Kelly Services (South San Francisco, CA)
- …Experience: 5+ years of regulatory experience in IVD, companion diagnostics, medical devices (Preferred experience: 7+ years of pre-market regulatory ... global RA department. + Seeks expert advice and develops device regulatory product strategies and identifies data...laboratory automation and software / hardware components of IVD medical devices . + Strong communication skills, both… more