Canadian Regulatory Affairs, European Union Regulatory Affairs, Medical Device, Quality/Risk Management
4 Year Degree
This position is responsible for ensuring all safety, performance, and regulatory requirements applicable to A-dec products are met for global markets by providing interpretations, guidance and trainings to various departments and leadership.
Provides interpretations of, guidance to, and training of regulatory requirements to various areas including executive leadership, management, and cross-functional teams – regarding design, development, evaluation, or marketing of products to ensure regulatory requirements are met.
Determines regulatory requirements, supports development of regulatory strategy, ensures progress is made toward project objectives and timelines, manages in-house and/or external testing, and maintains documentation.
Supports the Product Development Teams to ensure robust and consistent application of regulatory requirements in new designs.
Performs product tests and reviews, gathers necessary documentation, reviews results, and responds to inquiries regarding parts compliance. Also contributes to the Uncertainty of Measurement calculations for regulatory testing.
Prepares regulatory submissions as appropriate for approval of new or modified products. Ensures submissions are prepared and submitted accurately, completely and in a timely manner to meet business objectives, consulting with regulatory agencies as appropriate for clarification.
Participates in risk analyses of A-dec products and documents the results in a risk management file.
Participates in safety evaluations on new and existing products to identify safety hazards and reviews product changes for safety hazards and compliance to regulatory requirements.
Assists in maintaining the UL Data Acceptance Program, which allows regulatory compliance testing in-house instead of submitting products to UL, and contributes to agency lab compliance for ISO 17025 (requirements for the competence of agency Testing and Calibration Laboratories). Coordinates follow-up services’ factory inspections and resolves UL Variation Notices.
Determines documentation requirements for new and revised products and reviews technical publications for compliance.
Supports international product approvals by providing requested documentation, resolving open issues, and answering questions, in addition to resolving local inspector issues with products in the field.
Contributes to the accomplishment of Regulatory team objectives through effective communication and teamwork, and by providing advanced technical assistance as needed.
Remains aware and informed on the global regulatory changes and updates via industry affiliations and third-party collaboration as it relates to regulatory compliance (FDA, CE, global). Works with respective teams to ensure A-dec remains compliant to upcoming regulations and execute plans/changes towards compliance.
Assists in maintaining the Regulatory Compliance budget, creates and/or reviews, and/or approves procedures related to regulatory compliance.
Generally requires a bachelor’s degree in a related science or engineering discipline and 4-5 years of relevant professional or technical experience of increasing responsibility and difficulty in assignments or the equivalent combination of education and experience.
In depth knowledge of applicable regulations and requirements (e.g. ISO 13485, global medical device requirements, IEC 60601-1, IEC 80601-2-60, IEC 61010-1, ISO 14971, USA National Electrical Code, Canadian Electrical Code, and state and federal requirements).
Strong interpersonal skills to build strong rapport with cross-functional project team members, external agencies and government regulatory agencies.
Solid understanding of the purpose, requirements, and trends of regulations for medical device regulatory compliance.
Ability to work independently with minimal supervision and in a team environment.
Demonstrated ability to communicate effectively in oral, written, and illustration form.
Proficiency in Microsoft Office; Outlook, Word & Excel; working knowledge of relational database software.
Previous experience in the medical device industry is preferred.
Regulatory Affairs Professional Certification (RAC) preferred.
Ability to read, analyze, interpret common scientific and technical journals and legal documents, and train others in regards to regulatory requirements.
Intermediate project management skills and experience with the ability to manage regulatory projects effectively.
Drug Screen and Background Check required.
A-dec is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. In addition, A-dec will not discriminate against applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another. *VEVRAA Federal Contractor”
Internal Number: 2017-1894
About A-dec, Inc.
At A-dec, we're more than a dental equipment manufacturer. We're a family of employees banded together with a common goal: create quality solutions that simplify the lives of dentists worldwide.
We offer the most innovative solutions and back them with the finest customer service in the industry. Just like quality equipment, quality support is—and always will be—an integral part of the A-dec customer experience.
Come join the 1,000+ employees who grace our 50+ acre campus, delivering the quality and simplicity that’s made our products world famous for over 50 years.