Sr. Regulatory Affairs Specialist (Irvine)

Prismatik Dentalcraft is a division of Glidewell Dental.

Essential Functions :

• Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
• Maintains company registrations and device listings in the US, Canada, and the EU.
• Analyzes and reports department metrics.
• Supports and maintains technical files, MDD certifications, and declarations of conformity in support of EU product registrations / CE mark.
• Informs coordinator of product recalls.
• Performs and supports internal, external, and third-party audits.
• Maintains knowledge on current regulations and guidelines.
• Evaluates compliance with applicable regulations, project policies, and procedures
• Reviews and writes standard operating procedures (SOPs) and other RA / QA policies as necessary.
• Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
• Composes audit plans and reports.
• Conducts audits and inspections of GMP and non-regulated documentation.
• Tracks internal and external corrective and preventive actions.
• Performs other related duties and projects as business needs require at direction of management.

Education and Experience :

Pay Range : $83,000 - 120,000 / yr