Clinical Research Manager
Core
Manage US clinical usability studies for dental products (Restorative, Endodontics, Preventive) ensuring regulatory compliance and vendor management.
Role type
Senior Clinical Research Manager (Medical Devices)
Builds
Clinical Evaluation Reports, Post-Market Clinical Follow-Up protocols, Instructions for Use, Risk Management Files
Domain
Medical Devices / Dental / Regulatory Compliance
Required skills
Clinical study design and execution, Regulatory compliance (FDA, ISO 14155, EU MDR), Vendor relationship management, Cross-functional collaboration, Risk management (ISO 14971), Clinical documentation management
Preferred skills
Dentist or Hygienist licensure, Experience with 510k/CE tech files
Technologies
Microsoft Office (Word, Excel, PowerPoint), Clinical databases, Study management tools
Responsibilities
Design and execute clinical studies and Human Factor Usability studies; Prepare Informed Consent Forms and Case Report Forms; Select clinical study sites and investigators; Create and update Risk Management Files; Write and update Instructions for Use; Collaborate on DHF for 510k submission and CE tech files.
Seniority
Senior, hands-on IC