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Clinical Affairs Specialist

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DentalMonitoring

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Location:
United States , Austin

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Category:
Health and Beauty

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Clinical Affairs Specialist role at DentalMonitoring, a MedTech scale-up. The role involves leading clinical study design, ensuring regulatory compliance, managing study execution, and contributing to the company's clinical strategy within a supportive, dynamic work environment.

Job Responsibility:

  • Lead the design of clinical studies, from needs analysis through protocol writing, in collaboration with R&D, Product, Regulatory, and clinical experts
  • Design and challenge robust study designs, define statistical plans with biostatisticians, and maintain scientific and methodological watch to integrate best practices
  • Organize and execute study start-up: site selection and qualification, contracting, coordination of internal and external stakeholders, operational follow-up, and adherence to timelines/budgets
  • Ensure the proper conduct of studies by overseeing scientific, methodological, and regulatory compliance
  • Verify the quality, integrity, and completeness of collected data to ensure compliance with the protocol
  • Analyze and interpret results in collaboration with statisticians
  • Write study reports and contribute to the scientific valorization of the work (publications)
  • Contribute to clinical evaluation (CEP, CER) and post-market clinical follow-up (PMCF) in accordance with regulatory requirements
  • Participate in the company’s clinical strategy by proposing new ideas and conducting medico-economic studies to support product development

Requirements:

  • Engineering degree, Master’s in Regulatory Affairs, or similar field
  • 2 to 5 years of experience managing clinical studies, from design through dissemination of results
  • Proficient in GCP/BPC and the regulatory framework applicable to medical devices: MDR 2017/745, ISO 14155, ISO 13485
  • Structured, methodical, and comfortable in a multi-project environment
  • Adaptable and motivated by continuous learning
  • Excellent interpersonal skills and strong communication abilities
  • Can work autonomously while actively sharing information and contributing to team discussions

Nice to have:

  • Good knowledge of clinical trial management tools (eCRF…) and document management systems (eTMF)
  • Master basic statistical concepts and can independently perform simple analyses
  • Familiar with FDA clinical requirements, CE marking, and other international medical device regulations
  • Knowledge of coding/software development and artificial intelligence technologies applied to the medical field
  • Comfortable with literature research and scientific synthesis
What we offer:
  • Medical, Dental, and Vision Insurance
  • Short-Term & Long-Term Disability
  • Health Savings Account (HSA) and Flexible Spending Accounts (FSA)
  • Basic and Supplemental Life Insurance
  • Accident, Indemnity, and Critical Illness Coverage
  • 401(k) Retirement Plan
  • Paid Time Off (PTO) and Company Holidays

Additional Information:

Job Posted:
March 02, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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