Senior Regulatory Affairs Lead – Global Submissions

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

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.