Job Description
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.
- Experience in preparing (writing) domestic and international product submissions, required.
Pay Range: $83,000 - 120,000/yr
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