Regulatory and Clinical Specialist

🕒 vor 18 Tagen

⛰️ Colorado, Illinois, +1 weitere Bundesländer – Remote

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

💵 $85.000 - $95.000 / Jahr

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🚔 Compliance

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LivaNova

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1001 - 5000 Mitarbeiter

LivaNova PLC ist ein globales Medizintechnikunternehmen, das auf nahezu fünf Jahrzehnten Erfahrung und dem unermüdlichen Engagement basiert, das Leben von Patientinnen und Patienten weltweit zu verbessern. Unsere fortschrittlichen Technologien und bahnbrechenden Therapien bieten wirkungsvolle Lösungen zum Nutzen von Patientinnen und Patienten, medizinischem Fachpersonal und Gesundheitssystemen.

Beschreibung

• 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

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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