Job Description:
• Support Quality and Regulatory Affairs intelligence activities by monitoring new and changing regulations, standards, and regulatory guidance
• Maintain the organization's Standards e-system, standards watchlists, applicable standards inventory, regulatory intelligence records, trackers, and supporting documentation
• Coordinate the Regulatory Change Notification process for changes affecting registrations, licenses, certifications, technical documentation, labeling, or regulatory commitments
• Maintain regulatory correspondence and supporting records
• Serve as the QARA subject matter resource for FDA Automated Commercial Environment (ACE) and FDA/CBP medical device import requirements
• Coordinate and maintain FDA ACE data for imported finished goods, components, raw materials, and other regulated articles
• Support creation, review, and maintenance of FDA-related master data in SAP ECC6, SAP MDG, or other enterprise systems
• Partner with Trade Compliance, Supply Chain, Logistics, Customs Brokers, and Regulatory Affairs to support compliant importation
• Support resolution of FDA/CBP import-entry issues, including FDA Notices of Action, entry holds, detentions, document requests, and other inquiries
• Monitor changes to FDA/CBP import requirements and coordinate assessment and implementation
• Serve as an administrative point of contact for Notified Bodies and regulatory authorities
• Track regulatory commitments, information requests, audit actions, and required responses
• Support regulatory inspections, assessments, and Notified Body audits
• Maintain regulatory trackers, databases, certificates, licenses, registrations, and related documentation
• Support preparation, compilation, formatting, and administrative processing of regulatory submissions and notifications
• Prepare routine regulatory status reports and metrics
• Escalate complex regulatory strategy, legal interpretations, significant commitments, reportability decisions, and novel or high-risk import matters
Requirements:
• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, Supply Chain, Business, or related discipline preferred
• 3–5 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Trade Compliance, or a related medical device environment
• Experience with FDA ACE requirements and medical device importation strongly preferred
• Working knowledge of FDA medical device establishment registration, device listing, product codes, and import-entry requirements
• Familiarity with U.S. Customs and Border Protection (CBP) processes and working with customs brokers
• Familiarity with ISO 13485, FDA medical device requirements, and EU MDR
• Experience with regulatory intelligence or standards-management systems preferred
• Strong organizational, analytical, and project-coordination skills
• Strong attention to detail and ability to manage multiple regulatory deadlines
• Effective written and verbal communication skills
• Knowledge of regulatory intelligence and standards monitoring
• Knowledge of regulatory change coordination
• Knowledge of FDA ACE and medical device import compliance
• Knowledge of FDA/CBP regulatory requirements
• Knowledge of regulatory authority and Notified Body coordination
• Expected travel up to 10%
Benefits:
• Medical insurance
• Prescription drug insurance
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Participation in 401(k) savings plan
• Paid time off (PTO)
• Short-term disability
• Long-term disability
• Parental leave
• At-will employment
• Equal opportunity employment