Regulatory and Clinical Specialist

🕒 May 23

⛰️ Colorado, Illinois, +1 more states – Remote

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

💵 $85k - $95k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

LivaNova

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

Manufacturing • Healthcare • Biotechnology

LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. With a focus on medical devices, neuromodulation, and cardiac surgery, LivaNova offers advanced technologies and breakthrough treatments that provide meaningful solutions for patients, healthcare professionals, and healthcare systems. Headquartered in London and active in over 100 countries, LivaNova emphasizes bringing both clinical and economic value to its customers, being recognized as a market leader in cardiopulmonary and neuromodulation solutions.

📋 Description

• 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

🎯 Requirements

• 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.

🏖️ Benefits

• 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