INGENYX- Regulatory Affairs Coordinator

Teleflex•Templeton, MA

7d•$65,700 - $85,000•Onsite

About The Position

Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026. Ingenyx 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. For more information, please visit Ingenyx.com

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.

Nice To Haves

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

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.