Lead Risk and Compliance training initiatives at USAA, focusing on regulatory compliance. Drive effective learning programs and assess training needs within a complex environment.
About the role
- Regulatory Affairs Specialist managing regulatory applications for vascular health products. Ensuring compliance with FDA and international regulations for product registration.
Responsibilities
- Prepares robust regulatory applications for FDA or international regulatory agencies
- Provides regulatory input to product lifecycle planning
- Evaluates proposed preclinical, clinical, and manufacturing changes
- Acts as core team member for regulatory assessments
- Interfaces directly with FDA and other regulatory agencies
- Complies with FDA and international regulations
Requirements
- Bachelor's degree or equivalent combination of education and work experience
- Minimum of 2 years’ experience in a regulated industry (e.g., medical products, nutritionals, pharma, food)
- Strong verbal and written communications skills
- Ability to write and edit technical documents
- Experience working with cross-functional teams
- Attention to detail and ability to leverage, manage and engage others
Benefits
- Free medical coverage in the Health Investment Plan (HIP) PPO medical plan
- Excellent retirement savings plan with a high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit - an affordable path to getting a bachelor’s degree
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