Regulatory Affairs Specialist
BA/BS in Scientific discipline required. Engineering strongly
RAC certification desired
Ensure compliance to all internal, US, EU and other international
requirements and corporate policies and procedures for market
approval of medical devices/combination products.
Apply scientific principles to understanding safety and efficacy on
a wide range of products.
Prepare documentation for international submissions and ensure that
existing approvals and documentation are maintained. Communicate
with in-country RA personnel to facilitate global
Manage and implement data for UDI compliance for all divisional
Prepare Certificates to Foreign Government, organize and maintain
Reviews and approve labeling (Instructions for Use, labels,
promotional materials) for compliance to: standards, guidelines,
regulations, and regulatory approvals/clearances.
Performs responsibilities required by the Quality System and other
duties as assigned or requested.
Uses existing project management tools, and develops/implements new
tools as needed.
Regulatory Affairs Experience:
510(k), IDE, PMA (original/revision/supplements) preparation
Minimum 2 years experience in FDA regulated industry
Working knowledge of Medical Device Regulations (FDA required,
international a plus)
Must be able to multi-task and prioritize
Strong communication skills and organizational skills are
Proficiency with MS Office required, strong MS Excel