Required Regulatory Affairs (RA) Specialist.
Supporting the activities and processes required to assure that products manufactured and distributed are in compliance with all applicable regulatory requirements.
Assisting in the planning and preparation of submissions to obtain regulatory approvals for new and modified medical devices.
Preparation for tests, supporting engineering changes in the product/quality system.
Prep submission including 510(K), technical files.
AMAR submissions.
Notifications of changes.
Learning new standards and training relevant staff.
Requirements:
Familiarity with standards and regulation.
Minimum 2 years experience in RA for medical device companies.
experience as an RA for software companies-advantage.
Academic degree in Software, Precision Sciences - Advantage.
Attention to detail and ability to manage multiple tasks.
High verbal and written skills in English.