Regulatory Affairs Coordinator

🔥 15 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $65.7k - $85k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 1%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Teleflex

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $275k Venture Round on 2010-01

Healthcare • Manufacturing • Healthcare Insurance

Teleflex is a global provider of innovative medical devices and solutions, dedicated to supporting healthcare professionals and enhancing patient care. With a diverse portfolio that includes products for anesthesia, emergency medicine, interventional cardiology, and more, Teleflex aims to improve the health and quality of lives. The company emphasizes its commitment to education and customer support in the healthcare sector.

📋 Description

• 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

• 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

• 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