Regulatory Affairs Specialist, Sr.
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About The Position
The Regulatory Affairs Specialist, Sr. at Prismatik, a Glidewell Company, is responsible for preparing and submitting product registrations and submissions (510(k), PMA) to the FDA and other regulatory bodies. This role involves maintaining company registrations and device listings in the US, Canada, and the EU, analyzing and reporting department metrics, and supporting technical files, MDD certifications, and declarations of conformity for EU product registrations/CE mark. The specialist will also inform coordinators of product recalls, perform and support audits, and maintain knowledge of current regulations and guidelines. Additional responsibilities include evaluating compliance with applicable regulations, reviewing and writing standard operating procedures (SOPs), collaborating with technical staff, composing audit plans and reports, conducting audits and inspections, and tracking corrective and preventive actions. Other related duties may be assigned as business needs require.
