Regulatory Affairs Coordinator

Job overview

The Regulatory Affairs Coordinator role is listed as remote in Massachusetts, with Boston, MA shown as the listing location. The stated annual pay range is $65,700–$85,000. The coordinator supports Ingenyx’s Quality and Regulatory Affairs organization and its medical-device development and production services. The role maintains regulatory intelligence and records, coordinates regulatory changes, supports FDA and U.S. Customs import compliance, and tracks authority and Notified Body interactions. This operational coordination helps maintain accurate regulatory information and support compliant product importation and submissions.

What you'll do

• Monitor regulations, standards, and guidance
• maintain standards systems, watchlists, records, and trackers
• coordinate regulatory change notifications
• maintain FDA ACE data and regulatory master data
• partner with trade compliance, supply chain, logistics, customs brokers, and regulatory teams
• coordinate responses to FDA/CBP import issues
• track authority requests, commitments, audits, and responses
• maintain regulatory databases and documentation
• support submission preparation and status reporting.

What we're looking for

Skills & competencies

regulatory affairs coordinator

regulatory operations

medical devices

fda ace

cbp import compliance

regulatory intelligence

standards management

boston ma

remote

ingenyx

teleflex

$65,700–$85,000/year

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, prescription drug, dental and vision insurance
• flexible spending accounts
• 401(k) savings plan
• paid time off
• short- and long-term disability
• parental leave.

Why this role

Requires 3–5 years of experience in regulatory affairs, regulatory operations, quality, trade compliance, or a related medical-device environment; FDA ACE and medical-device import experience are strongly preferred.

About the employer

Teleflex is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.