- Mount Sinai Health System (New York, NY)
- **Job Description** The ** Project Manager II** will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/Clinical Research Sponsor ... compliance with regulatory requirements, and facilitating collaboration among multidisciplinary teams to meet project goals. The Project Manager II will work… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The Project Manager I oversees the operational aspects and scope of a specific project or ongoing department initiatives. S/he supports ... 5+ years with Bachelor's degree; 3-5 years of experience in program, project , or research administration within an academic setting preferred. + Familiarity with… more
- Unither Pharmaceuticals (Rochester, NY)
- PRODUCTION MAINTENANCE MANAGER Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and ... to the Michael Cifuentes, JOB SUMMARY: The Production Maintenance Manager is responsible for maintenance of all equipment used...a functional efficiency standpoint and in compliance with the FDA requirements to have and use a formalized equipment… more
- Chobani (New York, NY)
- …performance testing, safety validation, and regulatory compliance verification with project manager coordination Technical Documentation: Create engineering ... Summary The Senior Manager , Mechanical Engineer will serve as the technical...mentoring 2-3 engineers and collaborating with creative, product, and project management teams. Working alongside our Industrial Design team,… more
- Oracle (Albany, NY)
- …EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, ... Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and… more
- Wolters Kluwer (New York, NY)
- The **Principal SaMD Technical Program Manager ** plays a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This ... ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. They...dependencies. They provide oversight to various aspects of the project portfolio, coordinating meetings and project deliverable… more
- Lactalis American Group Inc. (Buffalo, NY)
- Quality Customer Relations Manager Buffalo, NY (http://maps.google.com/maps?q=2376+South+Park+Avenue+Buffalo+NY+USA+14220) Description Ready for more than just a ... of the Lactalis family of companies, is currently hiring a Quality Customer Relations Manager based in Buffalo, NY. The Quality Customer Relations Manager serves… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Northwell Health (Westbury, NY)
- …of the FDA . 10.Prepares and forwarding monitoring reports to program manager . Working with study staff to address any concerns. 11.Promotes overall compliance ... inspections and submissions. 9.Provides guidance on regulatory submissions to the FDA which may include an Investigational New Drug (IND), Investigational Device… more