INGENYX- Regulatory Affairs Coordinator

Position Summary

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.
This role serves as the central coordinator for regulatory and standards information and as a key resource for FDA and U.S. Customs and Border Protection (CBP) import requirements, including FDA Automated Commercial Environment (ACE) activities.

Principal Responsibilities

Regulatory Intelligence & Standards Management
•    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.
Regulatory Change Notification
•    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.
FDA ACE & CBP Import Compliance
•    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.
Notified Body & Regulatory Authority Coordination
•    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.
Regulatory Operations
•    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.

Education / Experience 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.

Specialized Skills / Other Requirements

•    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

Role Boundaries
The RA Coordinator serves as the operational SME for established FDA ACE and import-compliance processes and coordinates routine regulatory activities.
Complex regulatory strategy, legal interpretations, significant regulatory commitments, reportability decisions, and novel or high-risk import matters are escalated to Regulatory Affairs leadership, Trade Compliance, Legal, or other appropriate subject matter experts.'

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The pay range for this position at commencement of employment is expected to be between $65,700- $85,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.