INGENYX- Regulatory Affairs Coordinator

Summary

Ingenyx is a global provider of product development and production services for medical device manufacturers. The Regulatory Affairs Coordinator supports the Quality and Regulatory Affairs organization through regulatory intelligence, standards management, regulatory change coordination, regulatory authority interactions, and U.S. import regulatory compliance. The role also coordinates FDA Automated Commercial Environment activities and medical device import requirements.

Responsibilities

• Support ongoing Quality and Regulatory Affairs (QARA) intelligence activities by monitoring new and changing regulations, standards, and regulatory guidance by maintaining the organization's Standards e-system, standards watchlists, and applicable standards inventory
• Maintain regulatory intelligence records, trackers, and supporting documentation
• Coordinate the Regulatory Change Notification process for changes potentially 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 required for imported finished goods, components, raw materials, and other regulated articles
• Support creation, review, and maintenance of FDA-related master data in business systems such as SAP ECC6, SAP MDG, or other applicable enterprise systems, including establishment names and addresses, manufacturer/exporter information, importer-of-record details, FDA product codes, device listing references, and regulatory identifiers
• Partner with Trade Compliance, Supply Chain, Logistics, Customs Brokers, and Regulatory Affairs to support compliant importation of regulated products and materials
• Support resolution of FDA/CBP import-entry issues, to include coordination of responses to FDA Notices of Action, entry holds, detentions, requests for documents, or other FDA/CBP import-entry inquiries in partnership with Trade Compliance, customs brokers, and appropriate internal SMEs
• Monitor changes to FDA/CBP import requirements and coordinate assessment and implementation of applicable changes
• Serve as an administrative point of contact for Notified Bodies and regulatory authorities, under the direction of Regulatory Affairs leadership
• Track regulatory commitments, requests for information, 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

Skills

• •    3–5 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Trade Compliance, or a related medical device environment
• •    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
• •    Strong organizational, analytical, and project-coordination skills
• •    Strong attention to detail and ability to manage multiple regulatory deadlines
• •    Effective written and verbal communication skills
• •    Regulatory intelligence and standards monitoring
• •    Regulatory change coordination
• •    FDA ACE and medical device import compliance
• •    FDA/CBP regulatory requirements
• •    Regulatory authority and Notified Body coordination
• •    Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, Supply Chain, Business, or related discipline preferred
• •    Experience with FDA ACE requirements and medical device importation strongly preferred
• •    Experience with regulatory intelligence or standards-management systems preferred

Qualifications

Must Haves

• •    3–5 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Trade Compliance, or a related medical device environment
• •    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
• •    Strong organizational, analytical, and project-coordination skills
• •    Strong attention to detail and ability to manage multiple regulatory deadlines
• •    Effective written and verbal communication skills
• •    Regulatory intelligence and standards monitoring
• •    Regulatory change coordination
• •    FDA ACE and medical device import compliance
• •    FDA/CBP regulatory requirements
• •    Regulatory authority and Notified Body coordination

Nice to Haves

• •    Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, Supply Chain, Business, or related discipline preferred
• •    Experience with FDA ACE requirements and medical device importation strongly preferred
• •    Experience with regulatory intelligence or standards-management systems preferred

Benefits

• Medical, prescription drug, dental and vision insurance
• Flexible spending accounts
• Participation in 401(k) savings plan
• Various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered