Regulatory Affairs Coordinator

Teleflex

. Support Quality and Regulatory Affairs intelligence activities by monitoring new and changing regulations, standards, and regulatory guidance .

Posted 9/25/2026full-timeRemote • Massachusetts • United StatesMid-LevelSenior💰 $65,700 - $85,000 per yearWebsite

About the role

Key responsibilities & impact

Support Quality and Regulatory Affairs intelligence activities by monitoring new and changing regulations, standards, and regulatory guidance
Maintain the organization's Standards e-system, standards watchlists, applicable standards inventory, regulatory intelligence records, trackers, and supporting documentation
Coordinate the Regulatory Change Notification process for changes 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 for imported finished goods, components, raw materials, and other regulated articles
Support creation, review, and maintenance of FDA-related master data in SAP ECC6, SAP MDG, or other enterprise systems
Partner with Trade Compliance, Supply Chain, Logistics, Customs Brokers, and Regulatory Affairs to support compliant importation
Support resolution of FDA/CBP import-entry issues, including FDA Notices of Action, entry holds, detentions, document requests, and other inquiries
Monitor changes to FDA/CBP import requirements and coordinate assessment and implementation
Serve as an administrative point of contact for Notified Bodies and regulatory authorities
Track regulatory commitments, information requests, 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
Escalate complex regulatory strategy, legal interpretations, significant commitments, reportability decisions, and novel or high-risk import matters

Requirements

What you’ll need

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
Knowledge of regulatory intelligence and standards monitoring
Knowledge of regulatory change coordination
Knowledge of FDA ACE and medical device import compliance
Knowledge of FDA/CBP regulatory requirements
Knowledge of regulatory authority and Notified Body coordination
Expected travel up to 10%

Benefits

Comp & perks

Medical insurance
Prescription drug insurance
Dental insurance
Vision insurance
Flexible spending accounts
Participation in 401(k) savings plan
Paid time off (PTO)
Short-term disability
Long-term disability
Parental leave
At-will employment
Equal opportunity employment