Principal Regulatory Affairs Specialist – Software Devices

🕒 Outubro 29

🐊 Florida – Remoto

🐊 Florida – Remote

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

👻 Score fantasma 12%

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• Aberta há 12 dias.
• Sem salário divulgado.

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Treace Medical Concepts, Inc.

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🏭 Manufatura

🏥 Saúde

🧬 Biotecnologia

Manufacturing • Healthcare • Biotechnology

A Treace Medical Concepts, Inc. é uma empresa de dispositivos médicos ortopédicos em fase comercial, dedicada a aprimorar o tratamento cirúrgico das deformidades do joanete e a correção associada do mediopé. A empresa desenvolveu e patenteou o sistema Lapiplasty® 3D Bunion Correction™, que utiliza instrumentos e implantes especializados para a correção abrangente dos joanetes, abordando os três planos da deformidade. Essa solução inovadora atua na causa raiz dos joanetes e ajuda os pacientes a retomarem um estilo de vida ativo. A Treace também lançou o Adductoplasty™ Midfoot Correction System, ampliando ainda mais suas soluções para pacientes com hálux valgo.

Descrição

• Provide regulatory guidance to product development and sustaining project teams • Author US FDA premarket submissions, including 510(k) and Q-submissions, and international submissions for medical devices and software devices • Collaborate with Product Development, Operations, Marketing, and Quality for timely submissions • Serve as primary contact for regulatory agencies on assigned submissions • Negotiate submission data requirements and deliverables with regulatory authorities and product development teams • Author regulatory assessments for proposed product or process changes • Review advertising, promotional materials, and product labeling with Marketing, Sales, Legal, and Regulatory partners • Monitor regulatory landscape changes and author impact assessments • Interpret regulatory changes for implementation into company processes • Maintain US FDA and international registrations and device listings • Support the Unique Device Identifier (UDI) program and US FDA GUDID submissions • Maintain regulatory data, files, and daily regulatory operations • Participate in audits by regulatory authorities, certification bodies, or internal auditors • Mentor junior Regulatory staff and guide cross-functional understanding of regulatory requirements and processes • Develop Regulatory trainings • Develop Regulatory processes and procedures for departmental efficiencies

🎯 Requisitos

• Bachelor’s degree in Engineering, Science, or relevant technical discipline is required • Minimum of nine (9) years of Regulatory Affairs related experience in a medically regulated environment • At least seven (7) years in a medical device company (US FDA Class II) • Two (2) years of software medical device (SaMD, SiMD) experience • Regulatory Affairs Certification US (RAC) through Regulatory Affairs Professional Society (RAPS) is preferred

🏖️ Benefícios

• Full-time employment • Confidentiality of applicant information according to EEO guidelines • Equal employment opportunity protections • Drug-free workplace

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