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...
Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs act...
Job Description: Seeking an experienced Senior GxP Auditor to lead regulatory compliance activities, alignment of SOPs, and bracketing strategy across site and global teams in a highly regulated pharmaceutical manufacturing environment. R...
Responsibilities: Manage prototype and pilot builds for new product introduction, including operator training and coordination with production planning. Collaborate cross-functionally with Manufacturing and Quality teams to ensure proces...
Responsibilities: Lead CDM activities for assigned clinical studies, ensuring data quality and compliance with study timelines. Design and/or support the design of clinical databases in alignment with study protocols and requirements, in...
Job Description: The Statistical Programmer will contribute expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for Compass Pathways development programs. The role requires strong technical proficiency...
Roles & Responsibilities: 7 years of experience in medical device industry . Lead and support design verification and validation activities, including test method development and execution. Perform sample size selection and statistical ...
Job Description: We are looking for an energetic and self-motivated Regulatory Affairs professional who will provide global regulatory expertise and strategic leadership to our IVD product development teams. This position is focused on pre...
Roles & Responsibilities: 10+years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems. Perform review for GxP systems to ensu...
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...