Sr. Regulatory Affairs Specialist

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:

Bachelor’s degree in related field preferred

Minimum five (5) years of experience in Regulatory Affairs.

Minimum two (2) years of experience in software-based medical devices (e.g., SaMD or SiMD).

Experience in preparing (writing) domestic and international product submissions, required.

Pay Range: $86,000 - 120,000/yr