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.
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.
The Regulatory Affairs & Quality Manager maintains and improves certifications such as ISO 13485, as well as other relevant standards and regulations. They will oversee the Quality Management System (QMS), ensuring compliance and providing guidance, support, and training to the organization. The manager reports to senior management on the status of ISO systems and certifications.