- ZOLL Medical Corporation (Pittsburgh, PA)
- …ideal place to build your career.Job SummaryDirects the activities of the Quality Assurance and Regulatory Affairs department. Ensures the quality ... and regulatory systems are effectively implemented and maintained.Essential Functions + Pre-market approval of new and modified medical devices in domestic and international markets. + Post-market surveillance and medical device reporting in domestic and… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- ** Quality Assurance & Regulatory Affairs Compliance Specialist** **Position Summary** Catalent, Inc. is a leading global contract development and ... most difficult development and manufacturing challenges. The ** Quality Assurance & Regulatory Affairs Compliance Specialist** is responsible for … more
- Fujifilm (College Station, TX)
- **Position Overview** **Summary:** The Quality Assurance Regulatory Affairs Supervisor is responsible for supporting the electronic publishing of ... competencies, or as part of an individual's development plan. Regulatory Affairs supports all CMC regulatory...of two (2) years of related experience in a regulatory , quality , or similar position. + Prior… more
- Stryker (Kalamazoo, MI)
- …coaching. + Define team objectives in alignment with business and Regulatory Affairs and Quality Assurance (RAQA) goals, providing guidance, performance ... **Stryker** is hiring a ** Quality Manager, Software Design Assurance ** to... compliance, drive actions on findings, and partner with Regulatory Affairs to meet global compliance requirements… more
- Nissha Medical Technologies (Buffalo, NY)
- …standards. This position will be a crucial link between Regulatory Affairs , Design Engineering, and Quality Assurance . _Nissha Medical Technologies ... Regulatory Affairs Engineer Summary **Title:** Regulatory Affairs Engineer **ID:** 2823 **Department:** Quality **Location:** Buffalo, NY Description… more
- Edgewell Personal Care (Allendale, NJ)
- …support quality initiatives + Partner with Supply Chain, Regulatory Affairs , and Quality Assurance teams to drive continuous improvement initiatives ... or a related field (required) + 3+ years of experience in Supply Chain, Quality Assurance , Regulatory Affairs , or Operations Analytics + Exposure to … more
- Tecomet (Manchester, NH)
- **POSITION SUMMARY:** The Quality Assurance & Regulatory Affairs Manager oversees the quality management system (QMS) and ensures compliance with 21 ... device industry; + 5+ years of experience in quality assurance and regulatory affairs within a regulated industry (medical devices preferred); **WORK… more
- FlexStaff (Melville, NY)
- **Req Number** 162058 FlexStaff is seeking a Quality Assurance Associate for a long term temporary role with our client, a leading distributor of health care ... Rate: $27/hr This position is responsible to support the Quality Assurance and Trade Compliance teams in...803, 806 etc.) Responsibilities: + Data entry in various quality and regulatory management systems + Assist… more
- System One (Florham Park, NJ)
- …electronic submissions. + Coordinate with cross-functional teams, including Regulatory Affairs , Clinical Development, and Quality Assurance , to obtain ... work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance... regulatory affairs , clinical operations, and quality assurance in a team-oriented environment. +… more
- Bausch + Lomb (Harrisburg, PA)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance , Pharmacovigilance/GPSS ... ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,...timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house… more
- University of Miami (Miami, FL)
- …overseeing the creation and maintenance of policies and procedures as they relate to regulatory affairs , quality assurance , financial affairs , ... and UM policies and procedures. + Work with the Regulatory Manager and Financial Manager in the development and...protocol's development, and its preparation for implementation. Working with Quality Assurance staff, ensure all required systems… more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance , Medical Affairs ... strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. + Ensure communication of all safety… more
- Merck (De Soto, KS)
- …+ Prepare the Final Study Report + Maintain contact with all stakeholders (project leader, regulatory affairs , quality assurance etc.) and keeps them ... and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires… more
- Curia (Albuquerque, NM)
- …CAPA + Demonstrated understanding of laboratory, manufacturing, packaging, regulatory affairs , compliance, and quality assurance requirements for ... as commercial manufacturing operations. The role provides clear guidance on quality requirements consistent with cGMPs, regulatory expectations, and industry… more
- Cook Medical (Bloomington, IN)
- …stakeholders within the Division, Marketing, company Functions, and Operational Units (including R&D, Regulatory Affairs , Quality Assurance , Quality ... and support the overall business. Within scope of responsibility, ensure all quality , regulatory , compliance and product specific requirements are met.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of biopharmaceutical and/or pharmaceutical Operations, Process. Development, Finance, Supply Chain Management, Regulatory Affairs , Quality Assurance , and ... and components into finished goods. This role ensures the efficiency and quality of production processes, contributing to the overall success of Takeda's… more
- Cordis (Miami Lakes, FL)
- …management or other relevant field. + Candidates with backgrounds in legal, compliance, regulatory affairs , quality assurance , finance, internal audit, ... **Senior Manager - Compliance, the Americas** to lead and enhance our healthcare and regulatory compliance program in the US, Canada & Mexico, with a strong focus on… more
- AbbVie (North Chicago, IL)
- …interfacing with many groups external to PDS&T, for example: Manufacturing Operations, Regulatory Affairs , Quality Assurance , etc. Responsibilities: ... strategies, define project responsibilities and timelines o Author and review key regulatory documents, laboratory data, technical memos and reports. . The position… more
- Cook Medical (Bloomington, IN)
- …activities with a cross-functional team including SBU Product Management, Regulatory Affairs , Operations, Quality Assurance , Clinical Affairs , and ... modified products. This includes supporting product design, verification testing, regulatory compliance, process validation and manufacturing line establishment. A… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …with all project stakeholders at UCC, including stakeholders at multiple sites (eg, regulatory affairs , quality assurance , labeling, manufacturing, ... protocol development and product evaluations for design changes + Ensure regulatory compliance of all labeling materials + Facilitate cross-functional communication… more
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