- BD (Becton, Dickinson and Company) (San Diego, CA)
- …RAC certification preferred). + 10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device or SaMD (Software ... standards. + ** Regulatory Guidance and Frameworks** : Closely work with Regulatory Affairs team to define and own the development of industry-specific… more
- J&J Family of Companies (Irvine, CA)
- …partners including but not limited to R&D, Clinical Research, Business Development, Regulatory Affairs , Quality & Compliance, Health Economics & Market Access, ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Affairs **Job Category:**… more
- J&J Family of Companies (Irvine, CA)
- …R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs , Regulatory Affairs , Health Economics and Market Access, R&D, ... Safety Considerations, Good Clinical Practice (GCP), Industry Analysis, Medicines and Device Development and Regulation, Regulatory Affairs Management,… more
- Abbott (Alameda, CA)
- …discipline. * Minimum 8-10 years of experience in Quality Systems, Regulatory Affairs , or Quality Assurance within the medical device industry. * At least ... Product Return (NPR) will lead global medical device vigilance, post-market surveillance, and regulatory reporting...and complex regulatory processes. * Expertise in global medical device reporting regulations (FDA, MHRA,… more
- AbbVie (Irvine, CA)
- …and engage key stakeholders, including global strategic marketing, medical affairs , regulatory affairs , clinical development, and publication planning ... future medical devices with cells and tissues for purposes of establishing device proof of concept, completing regulatory submission-related studies (ISO 10993),… more
- Actalent (Irvine, CA)
- …of navigating complex situations and collaborating effectively with cross-functional teams, including Regulatory Affairs (RA) and Clinical Affairs (CA). . ... activities for a strategic M&A initiative in the medical device industry. This role demands a strong leader capable...in M&A environments is preferred. + Experience coordinating with Regulatory Affairs and Clinical Affairs … more
- J&J Family of Companies (Irvine, CA)
- …R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs , Regulatory Affairs , Health Economics and Market Access, R&D, ... or close out visits based on study need; + In EMEA, responsible for Regulatory Affairs related tasks associated with clinical trials and evidence generation.… more
- Actalent (Santa Clara, CA)
- …Skills + 2-3 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device or pharmaceutical industry. ... departments and offers exposure to different aspects of quality assurance and regulatory affairs . Work involves utilizing advanced complaint management systems… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Manufacturing. Demonstrates knowledge to provide design documentation to support global Regulatory filing strategies. Applies basic statistical techniques ... alongside Manufacturing and Operations, and provide design documentation to support global Regulatory filing strategies + Execute design verification testing… more
- Genentech (South San Francisco, CA)
- …role will primarily support Research and Early Development, Clinical Operations, Global Product Development, and Medical Affairs functions by providing ... highly experienced R&D attorney for life sciences/biotech clients, with deep experience in regulatory law related to early and late stage research and development of… more