About the Opportunity
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.
In this role, the successful candidate will:
• Maintains Regulatory Affairs certifications for domestic and international customers and distributors.
• 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 Corporation and its subsidiaries as needed.
• Maintains Quality Assurance and Quality Management Certificates (ISO and CE) for the Corporation and its subsidiaries interfacing with Notified Bodies.
• Reviews product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• 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 customer'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 customer 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 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred
• Strong problem solving, administrative, and data management skills.
• Demonstrated attention to detail.
• Team player with ability to work independently.
• Ability to multi-task, work under pressure and meet deadlines.
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