, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing...
, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing...
in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry 2-5 years...
in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry. 2-5 years Medical...
in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database...
and Adam. Proven experience with Unix and Windows operating systems. Understanding of the software development life cycle...
software development life cycle. Understanding of FDA guidelines. Good organization, time management, and attention to detail...
standards (e.g., ICH-GCP, CDISC). Requirements: Bachelor's degree in a life science, health science, pharmacy, public health...
Roles & Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Client procedures and guidelines, the duties and responsibilities for this position are: I d...
Job Summary: Ensure quality engineering activities for released products comply with regulatory and internal standards while supporting risk management, verification & validation, process validation, and sustaining engineering activities....
Roles & Responsibilities: Develop quality assurance documentation for new product development and regulatory submissions. Maintain and improve quality system processes by identifying and correcting deficiencies. Engage in design, develo...
Summary : The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to...
Job Description: Regulatory Affairs Specialist II with working knowledge of FDA, and CE marking requirements for IVD products. Client is currently transitioning from IVDD to IVDR (In Vitro Diagnostic Regulation). The RAS is responsible for...
Ensure quality engineering activities for released products comply with regulatory and internal standards. Collaborate with cross-functional teams to develop product risk management documentation, including Risk Management Plans, Risk Asse...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
Responsibilities: Documents and analyses design requirements for implementation. RTL coding, simulating and implementation. Pin assignment based on hardware design. Keeps the HW/SW interface documents up to date. Develops interface an...
Job Description: The main function of a Sr Engineer in this quality role is to focus on implementing and optimizing quality engineering practices related to Complaints Investigation, Post Market Surveillance and Risk Management while ensur...
Responsibilities: Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert...
Roles & Responsibilities: Ensure quality engineering activities for released products comply with regulatory and internal standards. Collaborate with cross-functional teams to develop product risk management documentation, including Risk...