- J&J Family of Companies (Titusville, NJ)
- …via matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality ... for the preparation and approval of essential documents for global regulatory filings. The CL will manage...Team and its affiliates + Assists Regulatory Affairs in the development of drug/ device … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... an integral role in the day-to-day functioning of the global medical safety organization. In this vital role, you...+ Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs,… 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
- J&J Family of Companies (Raritan, NJ)
- …within the medical device industry and with clinical evaluation report regulatory requirements **required** ; thorough understanding of global medical ... Market Surveillance, Clinical Affairs , Design Quality Engineers, R&D, and Regulatory Affairs relating to literature search and systematic review processes.… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …with broader quality goals and regulatory landscapes. + Deep understanding of global medical device /IVD regulations (eg, FDA 803/806, MEDDEV, QSR 820, ISO ... device /IVD industry employment position such as post-market surveillance, quality assurance, regulatory affairs , clinical affairs or product development +… 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
- Astellas Pharma (Northbrook, IL)
- …the global objectives of the organization and the unique and varying global , local and regional legal and regulatory requirements in a risk-balanced manner ... transactions of the Research, Technology and Manufacturing (T&M), Development, Medical Affairs , and Rx+ functions. The position holder also provides legal support… more
- Abbott (Maple Grove, MN)
- …+ Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs , Library Services, Product Performance Group (PPG), Quality ... Abbott is a global healthcare leader that helps people live more...mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more… more
- Cook Medical (Vandergrift, PA)
- Overview The Regulatory Affairs Specialist - Post Market Surveillance Specialist 2 will be involved in the development and generation of post market surveillance ... Cook Distributor and Notified Body. Responsibilities * Maintain an excellent understanding of global medical device regulations for in relation to Post Market… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Validation &** **Human Factors strategies** for successful submission in concert with Regulatory Affairs . + Conduct **gap analyses** of existing DVal/HF ... **use-related risk analysis (URRA)** and mitigation strategies in partnership with Medical & Regulatory Affairs . + Collaborate with ** Regulatory Affairs… more