Regulatory and Clinical Specialist

🕒 Maio 23

⛰️ Colorado, Illinois, +1 estados a mais – Remoto

⛰️ Colorado – Remote 🌽 Illinois – Remote 🤠 Texas – Remote

💵 $85.000 - $95.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

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LivaNova

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

LivaNova PLC é uma empresa global de tecnologia médica, construída sobre quase cinco décadas de experiência e um compromisso incansável de melhorar a vida de pacientes em todo o mundo. Nossas tecnologias avançadas e tratamentos inovadores oferecem soluções significativas em benefício dos pacientes, dos profissionais de saúde e dos sistemas de saúde.

Descrição

• Support the clinical evaluation activities • Review promotional materials and support regulatory submissions for active implantable medical devices for the Neuromodulation Business Unit • Author, prepare and/or update clinical evaluation plans (CEP) and reports (CER) for active implantable medical devices/systems in accordance with EU MDR requirements • Conduct systematic literature searches, appraisal, analysis, and summarization of data for state-of-the-art, safety and performance periodically • Manage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines • Responsible for regulatory authority queries on clinical evaluation • Prepare regulatory submissions assigned (510(k); IDE & IDE Supplements; PMA Supplements, notification of change, etc.) • Direct interface with Regulatory Agencies on assigned projects • Perform regulatory assessments of changes as part of the change management process • Promote a diverse and inclusive workplace culture in alignment with LivaNova values

🎯 Requisitos

• Minimum of a master’s degree in biomedical engineering, science or equivalent technical discipline • At least 5 years of previous related experience in medical writing and medical device regulatory affairs or a Ph.D. with at least 3 years of experience • Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) • Expertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature databases • Demonstrated experience in the development, writing and editing of regulatory/ clinical submissions (e.g. FDA PMA applications, IDE Progress Reports, technical files) • Medical writing experience with US and EU regulatory requirements understanding in medical device • Class III active-implantable experience, preferred • Demonstrates negotiation and conflict resolution skills • Demonstrates ability to rapidly learn new therapeutic areas • Proven abilities in demonstrating good judgment, building effective working relationships, excellent problem-solving skills.

🏖️ Benefícios

• Health benefits – Medical, Dental, Vision • Personal and Vacation Time • Retirement & Savings Plan (401K) • Employee Stock Purchase Plan • Training & Education Assistance • Bonus Referral Program • Service Awards • Employee Recognition Program • Flexible Work Schedules