Full Job Description
This position is responsible for Product Regulatory Compliance for the company's microscope product portfolio, primarily including Class I medical devices, across the Americas region, as well as Quality Management for the Bethlehem Service Site.
The role is responsible for supporting FDA regulatory compliance, FDA CDRH laser regulatory requirements, product registration activities throughout the Americas, and maintaining and continuously improving the ISO 9001 Quality Management System at the Bethlehem Service Site.
The position works closely with development and manufacturing sites in Japan and Germany, the Global QARA organization, and cross-functional stakeholders across the U.S. to ensure effective regulatory compliance and quality execution.
While the primary responsibility is for the existing microscope product portfolio, the role may also support regulatory and quality activities for additional product lines or new business initiatives as business needs evolve.
Key Responsibilities
1. FDA Product Compliance & Regulatory Operations
• Maintain FDA Establishment Registration
• Maintain FDA Device Listings
• Manage Official Correspondent activities
• Respond to FDA inquiries
• Maintain regulatory records
• Manage FDA regulatory accounts
2. Americas Regulatory Operations
• Product registrations in Canada and Latin America
• Support distributor registration activities
• Manage registration renewals
• Prepare and coordinate registration documentation
• Respond to regional regulatory inquiries
3. Bethlehem Site Quality Management
• Maintain the ISO 9001 Quality Management System
• Coordinate Internal Audits
• Coordinate External Audits
• Manage CAPA activities
• Maintain Standard Operating Procedures (SOPs)
• Support Change Control activities
• Coordinate training programs
• Manage Nonconformance processes
• Monitor and report Quality Metrics
• Support Management Review activities
4. Service Quality Oversight
• Review quality documentation
• Support corrective actions
5. Complaint & Product Quality Coordination
• Coordinate complaint handling and escalation
• Collect and coordinate information required for MDR reportability assessments
• Coordinate quality-related activities with manufacturing sites in Japan
• Communicate product quality issues across functions
• Support CAPA activities
6. Laser Product Regulatory Coordination
• Support regulatory compliance activities related to laser products, in collaboration with the site's Laser Safety Officer
7. Cross-functional Coordination
• Research & Development
• Manufacturing (Japan and Germany)
• Global QARA
• Service Operations
• Commercial
• Supply Chain
• FDA
• Certification Bodies
• Other internal stakeholders as required
Scope of Responsibility
• Legacy microscope product portfolio (including Class I medical devices)
• Laser products
• Bethlehem Service Organization
• Regulatory Operations across the Americas
• Scope may be expanded or modified based on business needs.
Qualifications
• Bachelor's degree or higher. Preferred: Engineering, Life Sciences, Medical Devices, Regulatory Affairs, Quality Assurance
• Minimum five years of experience in Medical Device Quality Assurance and/or Regulatory Affairs
• FDA regulatory experience
• ISO 9001 and/or ISO 13485 experience
• Internal Audit experience
• CAPA experience
• FDA Establishment Registration / Device Listing experience
• Cross-functional work experience
Preferred Qualifications
• FDA Device Listing
• FDA Establishment Registration
• FDA CDRH Laser Program
• Official Correspondent experience
• Americas product registrations
• ISO 13485
• Medical Device Complaint Handling
• Service Organization Quality Systems
• Experience working with Japanese companies or manufacturing sites
Core Evident Behaviors
Think Big - Sets ambitious goals, thinks beyond the immediate and works outside of own area for insight and inspiration to excel
Own the Outcome - takes a high degree of personal accountability and ownership, and embraces a customer-centric approach to prioritization, planning, and work
Test. Decide. Go. -Open minded, willing to try new things, balances risk with agility in a culture of learning and rapid growth, moves at pace to get the right things done
Kaizen Everywhere, Everyday - Solicits feedback to enhance effectiveness; continually identifies and drives improvement and new ways of working, operating, and thinking
Grow Together - Listens openly, embraces learning, and values diverse perspectives to spark ideas and build a stronger, more dynamic team
We realize that work is more than just a job for you.
It is a big part of your life, but not the only one. That's why we offer competitive salaries, an annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible hours, parental and adoption leave, on-site services and support networks, all so that you are ready to meet life's challenges.
We are committed to fostering a culture of well-being and inclusion by conveying the values that are most important to our employees.
