Global Regulatory Affairs Specialist - Dental Devices

Argen Corporation; San Diego (CA); On-site; USD 75,000 - 100,000; Full time

Benefits offered by this job

Medical, dental and vision Plans

401k with Employer Match

PTO

Employee Events

Wellness Programs

Discounts for home, travel, entertainment and relaxation!

Job summary

Argen Corporation in San Diego seeks a Regulatory Affairs Specialist to ensure compliance for regulated dental products. The role includes maintaining regulatory documentation, licensing, and supporting audits.

The ideal candidate has a Bachelor's degree and over 5 years in quality assurance or regulatory experience, preferably in the medical device industry. Our benefits include medical plans, a 401k, and employee events.

Qualifications

• 5+ years of experience in quality assurance and regulatory experience, or equivalent education.
• Experience in the medical device industry preferred.
• Working knowledge of cGMP regulations and ISO standards.

Responsibilities

• Ensure compliance with regulatory requirements for dental products.
• Maintain regulatory certifications for customers and distributors.
• Prepare for and facilitate audits regarding compliance.

Skills

Regulatory compliance

Quality assurance

cGMP regulations knowledge

Technical documentation

Education

Bachelor’s degree

Job description

Argen Corporation in San Diego seeks a Regulatory Affairs Specialist to ensure compliance for regulated dental products. The role includes maintaining regulatory documentation, licensing, and supporting audits.

The ideal candidate has a Bachelor's degree and over 5 years in quality assurance or regulatory experience, preferably in the medical device industry. Our benefits include medical plans, a 401k, and employee events.