Clinical Affairs Specialist - Austin🇺🇸

DentalMonitoring•Austin, TX

1d•Remote

About The Position

DentalMonitoring is a rapidly expanding MedTech scale-up. We are currently seeking talented individuals to join our team! 🦷 What is the added value of DentalMonitoring’s solutions for its clients? 🦷 ✦ Our SaaS monitors and optimizes orthodontic treatment for doctors and patients alike using our app and patient platform ✦ DentalMonitoring brings the first AI-driven technology to the oral healthcare space ✦ With more than 300 filed patents on our technology, we are leading an entire industry in how we approach the orthodontic experience ✦ Our handy tool, the Scanbox Pro™, helps to facilitate the easy detection of intraoral conditions ✦ Ultimately, we help patients achieve a better smile. Dental Monitoring was promoted in the Next40 for the third year in a row 🚀

Requirements

You hold an engineering degree, a Master’s in Regulatory Affairs, or a similar field.
You have 2 to 5 years of experience managing clinical studies, from design through dissemination of results.
You are proficient in GCP/BPC and the regulatory framework applicable to medical devices: MDR 2017/745, ISO 14155, ISO 13485.
You are structured, methodical, and comfortable in a multi-project environment.
You are adaptable and motivated by continuous learning.
You have excellent interpersonal skills and strong communication abilities.
You can work autonomously while actively sharing information and contributing to team discussions.

Nice To Haves

You have a good knowledge of clinical trial management tools (eCRF…) and document management systems (eTMF).
You master basic statistical concepts and can independently perform simple analyses.
You are familiar with FDA clinical requirements, CE marking, and other international medical device regulations.
You have knowledge of coding/software development and artificial intelligence technologies applied to the medical field.
You are comfortable with literature research and scientific synthesis.

Responsibilities

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.