- Jabil (Hunt Valley, MD)
- …SUMMARY The Sr. QA Associate h as the primary responsibility for hosting client/ regulatory audits that are in conformance with quality processes, standards and ... specifications to the client's expectations. . Directly interfaces with quality professionals, to coordinate schedules, hosting activities, and answering frequently… more
- Caris Life Sciences (Tempe, AZ)
- …Scientist will also serve as a liaison between Product Development and Quality Assurance/ Regulatory Affairs to ensure the product development process aligns ... with Regulatory Affairs to prepare and review regulatory submissions (eg, FDA 510(k), PMA, EUA,...Quality Management Systems (QMS) aligned with ISO 13485, FDA QSR, or IVDR. + Experience with IVD or… more
- Oracle (Augusta, ME)
- …designs are aligned with device-level safety, performance, and compliance needs. + Regulatory Compliance & Quality Alignment + Ensure adherence to medical ... and IEC 82304 (health software product safety and effectiveness). + Embed regulatory and quality requirements into the architecture and development lifecycle,… more
- LifeCenter Northwest (Bellevue, WA)
- …patient safety risk reduction strategies while aligning practices with CMS, OPTN/UNOS, FDA , AATB and other applicable regulatory requirements and best practices. ... reporting of patient and donor safety events to appropriate regulatory bodies and partners (eg OPTN/UNOS, FDA ,...regulatory requirements related to door and patient safety. Quality Improvement + Collaborate with the Quality … more
- Catalent Pharma Solutions (Harmans, MD)
- …ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance's (US and EU). + Strong focus on responsiveness, ability to multi-task, ... **Director, Quality Control Analytical** **Position Summary** + 100% on-site...in a biopharmaceutical or clinical research organization and/or federal regulatory experience is strongly preferred. + Experience in a… more
- Steuben Foods Inc (Elma, NY)
- Work Specifications - Responsibilities: + Responsible for food safety, quality and State & Federal regulatory requirements + Is able to perform Quality ... of CCP records generated. + Document, report, and review all non-conforming regulatory and quality manufacturing procedure (QMP) issues discovered during records… more
- Oracle (Bismarck, ND)
- **Job Description** Oracle Health is transforming its development and regulatory processes to meet heightened FDA , MDR, and ISO 14155 standards and address ... clinical oversight across Oracle Health, partnering with product development, engineering, quality , and regulatory functions to align clinical best practices… more
- Hologic (Marlborough, MA)
- …7 Subpart C (Recalls), 21 CFR Part 806 (Reports of Corrections and Removals), FDA Quality System Regulations, ISO 13485:2016, and EU Medical Device Regulation ... with regulatory requirements and maintaining the highest standards of quality and safety. In this critical role, you'll collaborate cross-functionally with… more
- Dentsply Sirona (York, PA)
- …to the appropriate competent authority. _Regulatory Reporting_ + Authors and submits high- quality , timely reports to health authorities (eg, FDA , EMA, MHRA, ... PSURs, PMCF, trend reports). _Cross-Functional Collaboration_ + Works closely with Regulatory Affairs, Safety Officers, Medical Affairs, Quality , Engineering,… more
- Abbott (San Diego, CA)
- …embedded medical devices and supporting software. + Collaborate with engineering, quality , and regulatory teams to apply secure-by-design principles throughout ... cybersecurity into the product lifecycle** , ensuring our devices meet regulatory requirements and protect patient safety. We're looking for a candidate… more