Manager, Regulatory

At A-dec, we do more than create the highest quality products and services for the dental industry; we strive to deliver a superior employment experience for each of our team members. With an environment that encourages and assists each person in developing to their highest potential, a career at A-dec is incredibly rewarding.

Overview

The Regulatory Manager maintains A-dec’s commitment to safe and compliant dental equipment worldwide by ensuring adherence to global regulatory requirements and standards. This manager leads a team of Regulatory Specialists and Engineers to develop and execute regulatory strategies, streamline processes, and maintain compliance throughout the product lifecycle. They support A-dec’s mission and vision by ensuring the safety and global compliance of A-dec products while balancing requirements, safety, and impact to the business.

JOB DUTIES AND RESPONSIBILITIES:

• Provides team leadership that facilitates efficient and effective regulatory activities for new products and sustaining products across the organization.
• Provides technical guidance and coaching to team through communicating job expectations, planning, monitoring, and appraising job results to ensure department goals are met and promoting employee personal growth and development.
• Leads activities necessary to ensure A-dec’s product compliance to applicable regulations and requirements including US FDA, Health Canada, EU, ISO 13485, MDSAP, and other international regulations.
• Guides the development and execution of regulatory strategy plans for global product submissions and registrations to obtain and maintain product approval. Interfaces with regulatory agencies as needed for pre-submission requirements and strategy and post-submission negotiations to ensure timely approval.
• Provides regulatory guidance throughout the product life cycle including product development, product approval/registration, labeling, promotional materials and regulatory evaluation of product changes.
• Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness; plans, prepares, and reviews complex regulatory documents for global product submissions.
• Serves as an organization-wide technical expert in advanced regulatory disciplines by applying an extensive and diversified knowledge of advanced regulatory techniques, procedures, and criteria.
• Maintains proactive awareness of evolving regulations, standards, and guidance; communicates impacts to leadership and stakeholders. Creates and adapts programs, policies, and practices to ensure continued compliance with applicable international, federal and state regulations.
• Collaborates with internal, cross-functional teams on assessments for product quality non-conformance and coordinates risk assessments for regulatory reporting with regulatory agencies.
• Continuously evaluates and improves regulatory procedures, workflows, and work instructions to streamline operations, enhances team effectiveness, and strengthens alignment with A-dec’s Quality Management System.
• Leads initiatives to standardize documentation, optimize submission processes, implement digital tools, and use metrics and automation to drive regulatory data integrity, efficiency, and continuous improvement.

QUALIFICATIONS:

Knowledge, Skills, and Abilities

• Knowledge of international standards and regulations (e.g., ISO 13485, MDSAP, FDA 21 CFR 820, CMDR SOR/98-282, Medical Device Directive 93/42/EEC, EU Medical Device Regulation 2017/745, ISO 14971, ISO 10993, IEC 60601).
• Must have excellent interpersonal skills; written and verbal communication for dealing with internal and external customers (e.g. A-dec department leaders, regulatory agencies), along with strong attention to detail and a high level of customer focus.
• Demonstrated ability to use critical thinking, solve problems independently and collaboratively, and escalate more complex issues to leader.
• Action-oriented leader with strong execution skills, deeply embedded in the daily function and technical execution of regulatory duties.
• Able to organize, coach, and lead cross-functional teams in addition to having strong organizational and time management skills; exercise good judgement using risk-based decision making and use resources effectively.
• Able to read, analyze, interpret common scientific and technical journals, financial reports and legal documents, and train others on regulatory requirements.
• Proficient with all Microsoft Office Suite applications and experience in project and database management.

Education and Experience

• Bachelor’s degree in biology, chemistry, engineering, regulatory affairs or related discipline.
• Ten years of re