Roles & Responsibilities : Documentation Management. Review and verify manufacturing Batch Production Records (BPRs) to ensure compliance with internal specifications, cGMP regulations, and ISO 13485 guidelines. Review production schedu...
Job Description: This role will be heavy on execution and technical writing - so just need someone with some familiarity in process validation and who is comfortable learning new equipment and executing. Requirements: BS Degree in Engin...
Summary : Develop qualification plans for supplier transfer projects and complete associated verification testing. Manage and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs). Roles & Responsibilities: C...
Responsibilities: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ...
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...
Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. This role combines technical writing expertise with project management skill...
Summary The Product Quality Engineer (PQE) display basic understanding of the Product Engineering and Quality Management System concepts. Utilizes sound statistical and engineering techniques/tools to investigate non-conformances. As Quali...
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...
Role Overview: The Product Quality Engineer (PQE II) will support product engineering and the Quality Management System, leading investigations, supporting change controls, and ensuring compliance with FDA, ISO, and internal quality system...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissio...