Regulatory Affairs Specialist

Argen Corporation

Regulatory Affairs Specialist ensuring compliance for dental products at Argen Corporation. Responsible for documentation, audits, and regulatory requirements for international operations.

Posted 6/12/2026full-timeSan Diego • California • 🇺🇸 United StatesMid-LevelSenior💰 $85,000 - $95,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory compliancequality assuranceregulatory documentationproduct registrationauditingtechnical documentationcGMP regulationsISO 1348521CFR Part 820MDR

Soft Skills

communicationjudgmentresearchinterpersonal skillsorganizational skills

Certifications

Bachelor's degreeCalifornia Notary PublicISO certificationCE certification