The Senior Associate will play a key role in supporting regulatory and human factors engineering initiatives. Responsibilities include drafting usability engineering files, conducting use related risk analysis, post-market surveillance data analysis, designing usability studies, and drafting reports.
Provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries and collaborate closely with multiple functions within Insmed and with external CROs/CMOs. Interpret regulatory guidance and regulations from various health authorities, as well as industry and government agency best practices and trends.
The Senior Specialist is responsible for developing the strategy based on regulatory requirements and for driving regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants.
We are looking for multiple MDR/IVDR Product Assessors with focus on Software Product Assessor to secure that the devices that we certify are efficient, safe, and meet the European requirements. Your job includes Identification of requirements, compliance assessment based on technical documentation, and acting as an expert in MD/IVD and SW compliance topics.
The Associate Director, Regulatory Affairs Devices and Combination Products works with internal and external partners to deliver products to patients, supporting regulatory objectives for the company’s development and marketed device/combination products, including coordination and management of device global submissions. This position focuses on eye care devices and next generational eye care medicinal delivery products.
This role supports data mapping of eCTD metadata from our legacy publishing system into our future state system and supporting activities in preparation of enabling eCTD 4.0 submissions. The project work will mostly be conducted in Excel, working against data extracts from Veeva Vault RIM and requires a deep understanding of eCTD structure, metadata and organization as well as experience with Veeva Vault RIM.
Ergomed is seeking Regulatory Affairs professionals experienced in managing global complex clinical studies. The role involves leadership and functional representation for projects, managing SSU/regulatory tasks, and ensuring compliance with standards. It requires preparing regulatory information for submissions to FDA, EMA, and national authorities, and providing expert advice to clients, plus training junior staff.
This position supports the Clinical Trial Patient Safety Organization by delivering high-quality data review, evaluating the quality of clinical trial patient safety data, and contributing to process improvement. The role involves worldwide surveillance of clinical trial patient safety data, timely assessment of reported data, and independent review of safety-related data.
The Manager, Study Start Up and Regulatory is responsible for developing the strategy based on regulatory requirements and for completing study start-up and regulatory deliverables based on an established regulatory SSU RA management plan. They actively assist senior management in securing new business by participating to BDMs and contributing to proposals/budgets.
Take your career to the next level with SGS. As a Senior Product Assessor, you will manage a team of Product Assessors, conduct technical documentation reviews, and ensure compliance with EU regulations and standards related to Active Medical Devices. The role involves collaborating with cross-functional teams, monitoring team performance, and assisting with technical queries, while ensuring a high level of service.