Regulatory Affairs Specialist

Job Description

Job Description

The Regulatory Affairs Specialist is responsible for ensuring foreign and domestic compliance for regulated dental products adhering to Quality and Regulatory compliance. This role works in conjunction with the Quality and Regulatory team to create, maintain and approve regulatory technical documentation, licensing, registrations and inspections in compliance with local, state, national and international regulatory requirements.

Schedule: M-F, 8:00 AM - 4:30 PM

Location: 5855 Oberlin Dr, San Diego, CA 92121

The day-to-day:

• Maintains Regulatory Affairs certifications for domestic and international customers and distributors.
• Ensures Argen uses relevant information and judgement to determine whether events or processes comply with laws, regulations, or standards.
• Reviews document changes, product labeling and in-house procedures to ensure regulatory requirements are met.
• Prepares for and facilitates internal, external, and third-party audits as necessary.
• Provides input for selecting the most effective regulatory course of action.
• Supports International Operations with foreign product registration through distributors according to each country’s regulatory requirements.
• Researches and responds to internal and external customer requests for regulatory information.
• Interprets regulatory rules or rule changes and ensures that they are communicated through corporate policies and procedures.
• Interfaces with the FDA concerning issuing Certificates to Foreign Government for The Argen Corporation and its subsidiaries as needed.
• Maintains Quality Assurance and Quality Management Certificates (ISO and CE) for The Argen Corporation and its subsidiaries interfacing with Notified Bodies.
• Maintains Declaration of Conformities for all Argen products and its subsidiaries.
• Reviews product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Accurately maintains the regulatory database to reflect all current and obsolete products.
• Communicates with the Secretary of State office, Department of State and Foreign Embassies or Consulates regarding authentication of documents to support the registration process.
• Supports product registration for Argen’s International Branches to meet foreign requirements for China, Canada, Taiwan, Korea, and others.
• Develops and generates customer-specific certificates of quality analysis and conformities to satisfy distributor and customer-specific needs.
• Completes supplier and subcontractor evaluations and approval forms for customers.
• Provides and submits regulatory documentation to notified bodies and Authorized Representative to support MDD/MDR requirements.
• Represents Regulatory Affairs and Quality team in yearly audits for quality and regulatory documentation including Technical Documentation.
• Contributes to Regulatory projects and deliverables to ensure Argen remains compliant to MDR and ISO requirements.

What does it take to be successful:

• Bachelor’s degree and 5+ years of progressive experience in quality assurance and regulatory experience, or equivalent combination of education and experience.
• Experience in the medical device industry preferred.
• Ability to comprehend and follow technical work instructions and standard operating procedures.
• Working knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 665/2022, MHLW MO 169 and TG(MD)R Sch3 preferred
• Maintain certification for California Notary Public.

Our Awesome Benefits!

• Medical, dental and vision Plans
• 401k with Employer Match
• PTO
• Employee Events
• Wellness Programs
• Discounts for home, travel, entertainment and relaxation!

About Us

At Argen, we’re in the business of creating healthy, confident smiles one case at a time. We are 500 team members strong. Founded more than 50 years ago as a precious metals company in South Africa, Argen has grown to become the largest dental zirconia manufacturer in North America, largest dental alloy provider worldwide, and leader in digital dentistry solutions with diverse product offerings. Our 140,000 square foot manufacturing center houses more than 150 3D printing and milling machines and operates six days a week. Argen embodies a culture of innovation, continuous improvement, and LEAN practices in support of our mission to help our dental laboratory customers succeed.