Clinical Affairs Specialist - Austin

Employer Industry: Med Tech

• Opportunity for career advancement and growth within the organization
• Work remotely with a flexible schedule
• Supportive and collaborative work environment with a focus on employee development
• Comprehensive benefits package including Medical, Dental, and Vision Insurance
• Paid Time Off (PTO) and Company Holidays
• Chance to contribute to innovative AI-driven technology in the oral healthcare space

• Lead the design of clinical studies, from needs analysis through protocol writing, in collaboration with R&D, Product, Regulatory, and clinical experts
• Organize and execute study start-up, including site selection, contracting, and coordination of stakeholders
• Ensure the proper conduct of studies by overseeing scientific, methodological, and regulatory compliance
• Analyze and interpret results in collaboration with statisticians and write study reports
• Contribute to clinical evaluation and post-market clinical follow-up in accordance with regulatory requirements

• Engineering degree, Master’s in Regulatory Affairs, or a similar field
• 2 to 5 years of experience managing clinical studies, from design through dissemination of results
• Proficiency in GCP/BPC and the regulatory framework applicable to medical devices
• Strong organizational skills and ability to work in a multi-project environment
• Excellent interpersonal and communication skills

• Knowledge of clinical trial management tools and document management systems
• Familiarity with FDA clinical requirements, CE marking, and international medical device regulations
• Basic understanding of statistical concepts and ability to perform simple analyses
• Knowledge of coding/software development and AI technologies in the medical field
• Experience with literature research and scientific synthesis

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