Careers That Change Lives
As a Principal regulatory Affairs Specialist, you will author submissions with clinical focus (including feasibility studies, pivotal studies, and expanding label indications) to obtain approval from regulatory bodies as applicable. The person in this role will also develop regulatory strategies that will provide the earliest approvals of clinical trials to bring diabetes products to the global markets.
A Day In The Life Preparation of submission to support approval of clinical studies (including IDE submissions/amendments/supplements, or competent authority approval of clinical studies) or expansion of indications (including PMA/510K submissions or reviewing/refining Clinical Evaluation Reports to support EU Technical files) for new or existing products to ensure timely approvals and market release. Review submission decisions/content issues with manager. Interact directly with agency personnel on defined matters to resolve potential regulatory issues and questions from regulatory agencies; establish and maintain good relationships with agency personnel. Team with various operating unit Regulatory Affairs Specialist (RAS) to provide regulatory support for new products/therapies and provide input for development of strategies that leverage opportunities and experiences across functions. Influences and inspires alignment with business goals internally and externally. Review of supporting documentation (e.g., clinical study documentation, labeling, etc.) to assure alignment with regulatory strategy. Be an active member of the product development core teams (including Clinical counterparts) and provides feedback on regulatory issues and questions pertaining to clinical studies. Maintain proficiency in worldwide regulatory requirements; monitor changes to regulatory requirements and communicating this information to departments within the operating unit that may be affected by these changes. Review and Revise SOPs, and other company departmental procedures to ensure quality system compliance. Additional tasks as defined.
Full-time
Northridge, California, United States
