For more than 10 consecutive years, A-dec was chosen as one of the top five places to work for in Portland Business Journal’s Oregon’s Most Admired Companies.  As the leading dental equipment manufacturer in North America, the reason is simple: we believe in people first. 

The Regulatory Compliance Specialist is responsible for the coordination, compilation and maintenance of various compliance activities and records to ensure A-dec products and systems are in compliance with applicable federal and international quality and regulatory requirements. The position provides support for the Quality/Regulatory department and partners across business functions to ensure efficient, compliant business processes and environment.

Responsibilities

• Identify requirements for new or revised quality system procedures and provide direction for the preparation and control of these documents. Help create, develop, and maintain procedures/records to support compliance with applicable quality/regulatory requirements company wide.
• Represent regulatory on various cross-functional teams to ensure compliance with requirements and procedures. Partner with teams, execute tasks, and ensure timely compilation of documents/records.
• Prepare, organize, and coordinate content to ensure compliance for product submissions to the FDA, Health Canada, EU, or other regulatory agencies.
• Prepare and maintain listings and registrations of medical devices and/or establishments with regulatory agencies.
• Manage the internal audit process, lead audit teams, and/or act as lead auditor to conduct ongoing internal audits in all areas of the company to ensure quality systems are functioning effectively in conformance to regulatory requirements. Guide and provide assistance to external auditors during official audits.
• Analyze audit results and provide direction for necessary corrective action related to process issues and continuously improve internal audit methods to ensure A-dec quality system standards are maintained.
• Gather, prepare and verify timely financial information for Sunshine Act reporting. Submit accurate information to appropriate regulatory agencies.
• Research and review information from external sources to stay abreast of regulatory and technical developments in the industry. Evaluate impact to A-dec in order to achieve and maintain regulatory compliance.
• Conduct regulatory reviews of customer complaints; assess and record the regulatory reportability decision.
• Assist in developing and delivering regulatory training for company employees on a wide variety of regulatory topics. Provide supplemental required training for internal auditors and coordinate professional training as a requisite for new auditors, as needed.
• Perform other duties as required.