Regulatory Affairs Specialist

Pac-Dent, Inc. is seeking a Regulatory Affairs Specialist to support regulatory submissions, product registrations, technical documentation, and ongoing compliance for medical devices in the United States and international markets. The role prepares and maintains regulatory records and submission materials, assesses product and labeling changes, and coordinates regulatory activities with cross-functional teams.

Responsibilities

• Prepare, compile, format, and maintain technical documentation and regulatory submission materials for medical devices in the United States, Canada, the European Union, and other markets as assigned
• Support preparation and maintenance of regulatory submissions and authorizations, including FDA 510(k) submissions and device listings, Canadian medical device licenses, and EU technical documentation and CE-marking records, as applicable
• Track registration status, renewal dates, submission commitments, and regulatory changes; maintain accurate records and follow up on required updates
• Review product labeling, instructions for use, claims, and promotional materials for consistency with approved or cleared indications and applicable regulatory requirements; escalate questions for review by QA/RA leadership
• Support regulatory assessments of new products, product changes, manufacturing or supplier changes, and changes to labeling or intended use; coordinate with cross-functional teams to obtain required information
• Maintain organized regulatory files and supporting records, ensuring documents are current, traceable, and readily retrievable
• Support post-market regulatory activities, including gathering information for complaint assessments, reportability evaluations, and regulatory reports or notifications, as assigned
• Assist with design-control documentation, audits, regulatory inspections, and responses to requests from regulatory authorities or certification bodies
• Monitor relevant medical-device regulatory requirements and guidance, summarize changes that may affect Pac-Dent products, and help communicate applicable requirements to internal teams
• Coordinate with internal departments and external partners to obtain accurate, complete, and timely information for regulatory activities

Preferred

• experience with FDA Class II medical devices
• FDA Class II Medical Device Experience

Benefits

• 401(k)
• 401(k) matching
• Health insurance
• Paid time off
• Paid sick leave

Company

• Dental supply manufacturer and wholesale dealer
• Brea, California, USA
• https://www.pac-dent.com/
• Founded in 1992
• 11-50 employees

Qualifications

• Bachelor's degree in regulatory affairs, life sciences, engineering, or a related field, or equivalent relevant experience
• At least one year of experience in the medical-device industry, including exposure to regulatory submissions
• Basic working knowledge of applicable medical-device regulations and standards, such as FDA requirements under 21 CFR, the EU Medical Device Regulation (MDR), and ISO 13485
• Strong written communication, document preparation, organization, and attention to detail
• Ability to manage assigned tasks independently, prioritize competing deadlines, and seek guidance when issues require escalation
• Ability to collaborate effectively with cross-functional teams and communicate regulatory requirements clearly
• Proficiency with Microsoft Office applications and the ability to maintain accurate electronic records
• Experience with FDA Class II medical devices
• At least one year of experience in the medical-device industry, including exposure to regulatory submissions;

Required skills

• 21 CFR, EU Medical Device Regulation (MDR), FDA Class II Medical Devices, ISO 13485, Medical Device Regulatory Affairs

Preferred skills

• experience with FDA Class II medical devices

Experience

• 1+ years