Manager, Regulatory

A-dec Inc.•Newberg, OR

About The Position

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.

Requirements

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.
Bachelor’s degree in biology, chemistry, engineering, regulatory affairs or related discipline.
Ten years of relevant professional experience with at least 3-5 years in a leadership experience.
Leadership may include people leadership, technical leadership, and/or project leadership with demonstrated ability to coach and mentor others, support team member development, and influence outcomes through effective leadership and collaboration.
Generally requires Regulatory Affairs Certification (RAC).

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.