{"id":1707093,"url":"https://alion.io/job/teleflex-ingenyx-regulatory-affairs-coordinator","title":"INGENYX- Regulatory Affairs Coordinator","company":{"id":1764434,"name":"Teleflex","domain":"teleflex.com","url":"https://alion.io/company/teleflex","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Administrative","role_family":"Administrative","seniority":"middle","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":65700,"max":85000,"currency":"USD","period":"year","gross":null,"usd_annual":85000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-25T00:00:00Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-10-28T10:08:22Z","board_verified":true,"closed_at":null,"days_open":34,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":34},"description":"Expected Travel: Up to 10%\nRequisition ID: 14464\nIngenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026.\nIngenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.\nFor more information, please visit Ingenyx.com\nPosition Summary\nThe 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.\nThis 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.\nPrincipal Responsibilities\nRegulatory Intelligence & Standards Management\nSupport 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.\nMaintain regulatory intelligence records, trackers, and supporting documentation.\nRegulatory Change Notification\nCoordinate the Regulatory Change Notification process for changes potentially affecting registrations, licenses, certifications, technical documentation, labeling, or regulatory commitments.\nMaintain regulatory correspondence and supporting records.\nFDA ACE & CBP Import Compliance\nServe as the QARA subject matter resource for FDA Automated Commercial Environment (ACE) and FDA/CBP medical device import requirements.\nCoordinate and maintain FDA ACE data required for imported finished goods, components, raw materials, and other regulated articles.\nSupport 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.\nPartner with Trade Compliance, Supply Chain, Logistics, Customs Brokers, and Regulatory Affairs to support compliant importation of regulated products and materials.\nSupport 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.\nMonitor changes to FDA/CBP import requirements and coordinate assessment and implementation of applicable changes.\nNotified Body & Regulatory Authority Coordination\nServe as an administrative point of contact for Notified Bodies and regulatory authorities, under the direction of Regulatory Affairs leadership.\nTrack regulatory commitments, requests for information, audit actions, and required responses.\nSupport regulatory inspections, assessments, and Notified Body audits.\nRegulatory Operations\nMaintain regulatory trackers, databases, certificates, licenses, registrations, and related documentation.\nSupport preparation, compilation, formatting, and administrative processing of regulatory submissions and notifications.\nPrepare routine regulatory status reports and metrics.\nEducation / Experience Requirements\nBachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, Supply Chain, Business, or related discipline preferred.\n3-5 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Trade Compliance, or a related medical device environment.\nExperience with FDA ACE requirements and medical device importation strongly preferred.\nWorking knowledge of FDA medical device establishment registration, device listing, product codes, and import-entry requirements.\nFamiliarity with U.S. Customs and Border Protection (CBP) processes and working with customs brokers.\nFamiliarity with ISO 13485, FDA medical device requirements, and EU MDR.\nExperience with regulatory intelligence or standards-management systems preferred.\nStrong organizational, analytical, and project-coordination skills.\nStrong attention to detail and ability to manage multiple regulatory deadlines.\nEffective written and verbal communication skills.\nSpecialized Skills / Other Requirements\nRegulatory intelligence and standards monitoring\nRegulatory change coordination\nFDA ACE and medical device import compliance\nFDA/CBP regulatory requirements\nRegulatory authority and Notified Body coordination\nRole Boundaries\nThe RA Coordinator serves as the operational SME for established FDA ACE and import-compliance processes and coordinates routine regulatory activities.\nComplex 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.'\nThe 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.\nIf 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.\nAt Ingenyx, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.\nIngenyx is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. 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