Jurist/in
Core
Ensuring products comply with regulations and standards by providing strategic input for product development, obtaining and maintaining product registrations and approvals, communicating with authorities, and monitoring regulatory changes.
Role type
Regulatory Affairs Specialist (Medical Devices)
Builds
Product registrations and approvals for medical devices
Domain
Medical Devices / Regulatory Compliance
Required skills
Regulatory strategy development, submission preparation for international authorities, knowledge of EU MDR (2017/745), knowledge of FDA requirements, project leadership or coordination
Preferred skills
Experience in medical device regulatory affairs
Technologies
EU MDR, FDA regulations
Responsibilities
Prepare and submit approval applications to international authorities for product approvals and changes; Provide regulatory expertise and support in product development projects; Develop regulatory strategies for product changes and new products on a global level; Lead or coordinate regulatory projects, tasks, or initiatives to ensure compliance