Sr. Regulatory Affairs Specialist

PRISMATIK DENTALCRAFT, INC.; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

A dental product company in California is looking for a Regulatory Affairs Specialist. The role involves preparing and submitting product registrations to the FDA, maintaining compliance with regulations across the US, Canada, and EU, and conducting audits. Candidates should have a Bachelor's degree and 5+ years of experience in Regulatory Affairs, especially in product submissions. This position supports the company's mission of delivering top dental solutions.

Qualifications

• Minimum five years of experience in Regulatory Affairs.
• Experience in preparing domestic and international product submissions required.

Responsibilities

• Prepare and submit product registrations to FDA and other regulatory bodies.
• Maintain company registrations and device listings in the US, Canada, and the EU.
• Conduct audits and inspections of GMP and non-regulated documentation.

Education

Bachelor’s degree in related field

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.