Roles & Responsibilities: Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits alo...
Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. A...
Job Summary: Overall technical leadership and responsibility for realization of a new product release and sustaining activity. Translation of user requirements, requirements management, top-level design, feasibility of potential solution...
Requirements: Bachelor's degree in Mechanical Engineering from ABET accredited university EIT or Professional Engineer (PE) licensure preferred, but not required 7+years of practical application of mechanical facilities design eng...
, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing...
's degree in engineering, LifeSciences, or a related field 3+years of experience in validation within a regulated...
Job Summary: PMI Qualified Operations and Product Development Experience in Devices 10 – 15 years' experience in Device and Pharma industry. Lean black belt or Green with significant facilitation / workshop experience proficient in Pr...
Roles & Responsibilities: Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits alo...
Job Description: Independently conducts development work as part of a major research and/or development project. Receives minimal technical direction/review on broad scope or complex projects. Viewed as an expert in one or more in-house...
Responsibilities: Ensure departmental or functional training plans in place and appropriate Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deli...