What are the responsibilities and job description for the Quality and Regulatory Affairs Manager position at DENTALEZ?
We're hiring a Quality and Regulatory Affairs Manager
DENTALEZ is a dental supply company committed to providing state-of-the-art dental practice solutions for unlimited interconnectivity, choice, and control. A true dental pioneer, the company stands as an indispensable industry staple with over 100 years of experience in dental equipment
About the Role
We are seeking a Quality and Regulatory Affairs Manager to lead our quality assurance and regulatory compliance efforts. This role is essential in ensuring our medical device products meet all applicable global standards and regulations. As the subject matter expert in Quality and Regulatory Affairs, you will manage our Quality Management System (QMS), oversee regulatory processes, and support company-wide compliance and continuous improvement initiatives.
Qualifications
Bachelor's degree in law, medicine, pharmacy, engineering, or relevant scientific discipline.
Minimum 1 year of experience in regulatory affairs or quality management systems for medical devices.
ASQ Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) preferred.
Strong working knowledge of:
ISO 13485
FDA 21 CFR Part 820
FDA 510(k) process
CE marking
Health Canada and EU MDR/MDD
Experience with FDA registration, device listings, and certificates to foreign governments.
Skilled in interpreting regulatory standards and implementing compliant processes.
Strong communication, presentation, and technical writing skills.
Effective cross-functional collaboration with departments such as Legal, Engineering, Marketing, and Operations.
Proficient in Microsoft Office and Windows-based applications.
Key Responsibilities
Serve as the subject matter expert in quality and regulatory compliance for global markets.
Lead and maintain the company's Quality Management System (QMS), leveraging current best practices.
Ensure compliance with ISO 13485, FDA regulations, EU MDR, Health Canada MDR, and other international standards.
Develop and implement metrics to monitor QMS effectiveness and performance.
Maintain ISO procedures and GMP requirements related to medical devices.
Manage RMA, QC Inspection, document control, acceptance activities, calibration, QMS training, and quality engineering functions.
Oversee post-market surveillance, adverse event reporting, internal and external audits.
Partner with suppliers to uphold quality and compliance standards.
Advise internal teams on regulatory requirements and influence strategic decisions.
Coordinate with external consultants and regulatory bodies as needed.
Lead the CAPA and Supplier CAPA programs, ensuring timely and effective resolutions.
Provide oversight and ensure consistent updates to QMS documentation.
Additional Requirements
Ability to manage multiple projects and meet deadlines under pressure.
Strong analytical and decision-making skills.
Comfortable in a fast-paced, high-stakes environment.
Willingness to travel occasionally as needed.
Able to sit or stand for extended periods and perform computer-based tasks.
Why Join Us?
At DentalEZ, we are committed to innovation, compliance, and delivering high-quality medical devices that improve lives. You'll be part of a dynamic team that values integrity, continuous improvement, and professional growth.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, disability or protected veteran status or any other status protected by law.
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