Regulatory Affairs Specialist
Posted on 3/24/2023
Remote • United States
Experience Level
Desired Skills
  • Bachelor's degree in a scientific discipline or related technical field
  • Minimum of 5+ years of medical device regulatory experience or an advanced degree, with a focus on regulatory affairs and 2 years of medical device experience
  • Working knowledge of the Quality System Regulation 21 C.F.R. 820, ISO:13485:2016 and international regulations for medical devices (including but not limited to: EU, Canada, Brazil, Australia, and Japan)
  • Experience modifying existing projects and device files to conform to new and changing standards and regulations
  • Experience working with devices that incorporate software or experience with software as a medical device (SaMD) preferred
  • Availability to work hours that accommodate foreign time-zones and flexibility to travel occasionally (less than 25% of the time)
  • Prepare US and international regulatory submissions and registrations in strategic markets by liaising with our partners and leveraging internal and external resources
  • Perform regulatory assessment of device classification and propose regulatory pathways for market access in the US and Internationally
  • Manage and maintain regulatory documents for submissions including correspondence with regulatory agencies worldwide
  • Participate in Risk Management activities as part of the Software Development Lifecycle (SDLC) and conduct risk assessments for device changes
  • Performing regulatory assessments for design and labeling changes, and documenting memorandums to file (MTF)
  • Review and assess technical documentation and testing protocols to ensure compliance with special controls and other regulatory requirements

201-500 employees