Regulatory Affairs Coordinator

🕒 Setembro 25

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $65.700 - $85.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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Teleflex

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

🏭 Manufatura

⚕️ Seguro de Saúde

💰 $275.000 Venture Round em 2010-01

Healthcare • Manufacturing • Healthcare Insurance

A Teleflex é uma fornecedora global de dispositivos e soluções médicas inovadoras, dedicada a apoiar profissionais de saúde e aprimorar o cuidado ao paciente. Com um portfólio diverso que inclui produtos para anestesia, medicina de emergência, cardiologia intervencionista e outras áreas, a Teleflex tem como objetivo melhorar a saúde e a qualidade de vida das pessoas. A empresa enfatiza seu compromisso com educação e suporte ao cliente no setor de saúde.

Descrição

• 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

🎯 Requisitos

• 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%

🏖️ Benefícios

• 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