A-dec Inc. · 4 hours ago
Manager, Regulatory
Newberg, OR
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expA-dec Inc. is committed to delivering high-quality products and services for the dental industry while providing a rewarding employment experience. The Regulatory Manager will lead a team to ensure compliance with global regulatory standards, develop regulatory strategies, and maintain product safety throughout the lifecycle.
HardwareHealth CareManufacturing
No H1B
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
Qualification
Required
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)
Company
A-dec Inc.
Innovation. Creativity. Evolution. If these are words you’re passionate about, we should chat.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Michael J. Highland
Chief Financial Officer
Travis Morgan
HR Business Partner - Manufacturing
Recent News
Seattle TechFlash
2025-09-09
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