Clinical Affairs Specialist - Austin
5 hours ago
Job description
DentalMonitoring is a rapidly expanding MedTech scale-up. We are currently seeking talented individuals to join our teamWhat 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
Clinical Affairs Specialist Role
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.
What the Clinical Affairs team offers
A supportive, dynamic, and stimulating work environment where performance and enjoyment go hand in hand.
Cross-functional projects involving close collaboration with many internal departments (R&D, Production, Marketing, BI, Finance…) as well as external healthcare professionals (orthodontic and dental practices).
You will be successful in this role if
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.
It would be fantastic if
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.
Our work environment
At DentalMonitoring Our Employees Thrive Because
Collaboration is a core value:
Our team of researchers, doctors, developers, and salespeople—in fact, all of our stakeholders—work together to put our customers first
DentalMonitoring is a diverse, multicultural company, with more than 35 nationalities represented across our teams
What we bring to our employees
Your ideas will be heard Our culture promotes initiative, ownership, and feedback
We are committed to supporting your professional development, recognizing that continuous learning is essential
We place significant importance on work-life balance
Here are some perks that we offer our employees:
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
Austin, Texas / Remote
DentalMonitoring is an equal opportunity employer and offers an intercultural and inclusive workplace. The diversity of our teams is one of our strengths. We work every day with more than 35 nationalities across different countries all over the world. We welcome and encourage applications from people with disabilities. We are committed to providing appropriate accommodation.
Similar jobs
We are seeking a Regulatory Affairs Specialist III to join our team in Austin, Texas. As part of the Regulatory Affairs group, you will be responsible for defining and implementing regulatory strategy. · ...
2 weeks ago
This position is located in Austin, Texas, and is part of the Regulatory Affairs group. The ability to work in-office in Austin, TX is required for 50% of the time. · Write regulatory documents to agencies. · Engage regulators in oral and written communications. · ...
2 weeks ago
h2>Job summary · p>This position is located in Austin, Texas, and is part of the Regulatory Affairs group. This position functions within an office setting, following a typical Monday to Friday work schedule. The ability to work in-office in Austin, TX is required for 50% of the ...
1 month ago
About Neuralink: We are creating devices that enable a bi-directional interface with the brain. Team Description: Join the Quality Team where our mission is to ensure compliance with relevant regulatory standards. Job Description: As Regulatory Affairs Specialist at Neuralink you ...
1 month ago
The Austin Community College is seeking a Specialist in Veterans Affairs to provide information and guidance to students and others regarding the Department of Veterans Affairs educational benefits. · The job involves providing assistance with various job duties of the Financial ...
2 weeks ago
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 ...
19 hours ago
+The Regulatory Affairs Specialist will work with supervision to bring new and modified medical devices to market and ensure ongoing compliance. · +Acts as a core team member on sustaining and new product development projects, · Develops regulatory strategies for new products, · ...
1 month ago
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. · ...
4 weeks ago
We are seeking a Senior Regulatory Affairs Specialist to join our team in Austin,TexasorShoreview,Minnnesota.This role combines knowledge of scientific regulatoryand business issues to ensure compliance with global regulatory requirements.The successful candidate will have experi ...
1 month ago
To provide information and guidance to students regarding Department of Veterans Affairs educational benefits. · ...
2 weeks ago
Job Posting Closing Times: Job postings are removed from advertising at 12:00 A.M. on the closing date e.g., at midnight on the day before the closing date. · Austin Community College employees are required to maintain a domicile in the State of Texas while working for the colleg ...
1 day ago
The Regulatory Affairs Specialist will work with supervision to bring new and modified medical devices to market and ensure ongoing compliance. · ...
1 month ago
THECB - Program Specialist IV (Academic and Health Affairs)
Only for registered members
This position manages all new academic program proposal submissions and program inventories through data entry and maintenance, reporting, and process management. · ...
1 month ago
Determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results for BioLife Plasma Services. · ...
1 month ago
As a part of the Global Affairs Vendor Management Operations (GA VMO) team provides leadership and operational oversight for all vendor relationships within Global Affairs. · Manage VMO onboarding workflows as the primary escalation point and functional advisor. · Establish and m ...
1 month ago
We're looking for a Manager of Public Affairs and Marketing in Austin. In this position, you'll lead regional storytelling, market-level brand visibility, and community engagement strategies across campuses. · Develops and executes strategic public affairs and marketing plans to ...
1 month ago
As a Supplier Strategy and Operations Specialist for Global Affairs, you will serve as a driver of our Vendor Management Office within the Solutions Enablement team. · ...
1 month ago
As a part of the Global Affairs Vendor Management Operations (GA VMO) team provides leadership and operational oversight for all vendor relationships within Global Affairs. You will ensure that GA's engagements with its extended workforce are compliant cost-effective and aligned ...
4 weeks ago
· info_outlineXIn accordance with Washington state law, we are highlighting our comprehensive benefits package, which is available to all eligible US based employees. Benefits for this role include:Health, dental, vision, life, disability insurance · Retirement Benefits: 401(k) ...
3 days ago
Aypa Power is seeking a Public Affairs Manager to help advance Aypa's policy and stakeholder engagement priorities in key markets. · ...
3 weeks ago