Global Regulatory Affairs Specialist for FDA Submissions

PRISMATIK DENTALCRAFT, INC.; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Prismatik Dentalcraft, a division of Glidewell Dental, is seeking an experienced Regulatory Affairs Specialist to support global regulatory compliance and drive high-impact submissions. You will lead FDA 510(k)/PMA filings, maintain international registrations, support audits, and develop SOPs while partnering with technical teams to ensure products meet regulatory standards.

The role requires interpreting regulations, managing complex documentation, and guiding teams through compliance

Qualifications

• 2+ years of Regulatory Affairs experience.
• Experience preparing domestic and international product submissions.

Responsibilities

• Lead FDA 510(k)/PMA filings and maintain registrations.
• Prepare and submit domestic and international submissions.
• Coordinate with FDA and other regulatory bodies during review.
• Develop SOPs and support audits.
• Maintain RA files and device listings globally.

Skills

Regulatory knowledge

FDA submissions

Documentation management

MS Office

Analytical skills

Time management

Attention to detail

Team collaboration

Education

Bachelor’s degree preferred

Job description

Prismatik Dentalcraft, a division of Glidewell Dental, is seeking an experienced Regulatory Affairs Specialist to support global regulatory compliance and drive high-impact submissions. You will lead FDA 510(k)/PMA filings, maintain international registrations, support audits, and develop SOPs while partnering with technical teams to ensure products meet regulatory standards.

The role requires interpreting regulations, managing complex documentation, and guiding teams through compliance