, compliance, and implementation activities in a regulated life sciences environment. The ideal candidate will have hands... skills Experience in life sciences or pharmaceutical domain Exposure to cloud-based system validation Understanding...
and validation of data management software Requirements: BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics...
: Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field (master's preferred...
: Bachelor's degree in engineering, Computer Science, IT, or Life Sciences. 6+ years of experience in medical device...
requirements and best practices. Education & Experience : Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences...
requirements and best practices. Education & Experience Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences...
technology, or science with 5-7 years of related experience. Experience with technical development, material sciences...
of regulatory responses and may participate in meetings. Requirements: Bachelor's degree in the sciences; advanced degree (e.g...
Job Description: The Contract Lead Programmer serves as a senior, hands-on programmer responsible for managing statistical programming activities across multiple clinical trials and therapeutic areas. The role oversees external CRO partner...
Roles & Responsibilities: Lead smoke studies, including airflow visualization and identifying stagnant air or pass-through airflow issues. Support pressurization challenge studies and evaluate what happens during loss of differential pre...
Responsibilities: Defines scope of quality control activities with the document author and the required source documents and data required. Conducts independent quality control review of documents per applicable checklist by checking aga...
Responsibilities: Support preparation, review, and submission of CMC sections for U.S and global regulatory filings (INDs/CTAs, amendments, and BLAs/MAAs). Coordinate with internal stakeholders to gather technical information and ensure ...
Responsibilities: The Regulatory Affairs Specialist will be responsible for supporting regulatory activities for existing US FDA class III medical devices. This role provides support to currently marketed products, involves evaluating pr...
Responsibilities: We're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function. You will work collaboratively with other functional leaders across the organization, as well as ex...