Regulatory Affairs Specialist

Description
Review labeling, training, and promotional material
Support product and shipping release.
Maintenance of FDA’s GUDID database
Technical file update and reviews
Review of External Standards
Support business with government queries and registration documentation requirements.
Review Change Orders and assess regulatory impact of product changes on US and/or International regulatory strategy and submissions
Support post market regulatory compliance activities for US/International product approvals
Assist with the development and maintenance of regulatory affairs department procedures
Comply with applicable FDA and international regulatory laws/standards
Ensure relevant ISO and FDA Export requirements are met, as required
Performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Compiles all materials to support submissions, license renewal and annual r...