Senior Specialist, Americas Product Compliance & Site Quality

Evident Europe GmbH•Lower Saucon Township, PA

About The Position

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.

Requirements

Bachelor's degree or higher
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

Nice To Haves

Preferred: Engineering, Life Sciences, Medical Devices, Regulatory Affairs, Quality Assurance
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

Responsibilities

Maintain FDA Establishment Registration
Maintain FDA Device Listings
Manage Official Correspondent activities
Respond to FDA inquiries
Maintain regulatory records
Manage FDA regulatory accounts
Product registrations in Canada and Latin America
Support distributor registration activities
Manage registration renewals
Prepare and coordinate registration documentation
Respond to regional regulatory inquiries
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
Review quality documentation
Support corrective actions
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
Support regulatory compliance activities related to laser products, in collaboration with the site's Laser Safety Officer
Research & Development
Manufacturing (Japan and Germany)
Global QARA
Service Operations
Commercial
Supply Chain
FDA
Certification Bodies
Other internal stakeholders as required