The Regulatory Affairs Specialist is responsible for preparation of submissions with a primary focus on EU / MDR, along with supporting all other regions registrations.
Responsibilities :
Regulatory support for product life cycle on product teams
Prepare STED technical files
Offer support and guidance for post market activities
Prepare and support 510(k)
Education / Experience :
BS degree
4 years’ experience in regulatory position in the medical device space
Experience with regulatory for EU / MDR and Article 120.
Experience making changes to technical files.
Ability to travel internationally up to 15% is required.