As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives.
The Regulatory and Clinical Specialist will support the clinical evaluation activities, review promotional materials and support regulatory submissions for the active implantable medical devices for the Neuromodulation Business Unit. The Regulatory and Clinical Specialist is a liaison with the organization working with various groups to effectively communicate and collaborate on the deliverables and meet the project deadlines in line with the regulatory requirements.
General Responsibilities
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, including documentation generation, initiation of the review process, discussions on proposed revisions, and document completion in collaboration with other team members.
Responsible for regulatory authority queries on clinical evaluation
Support the Compliance Review Board process by reviewing promotional materials for compliance with applicable regional regulation as the Regulatory representative.
Maintains a continued awareness and understanding of EU and FDA regulations and guidance documents.
Prepare regulatory submissions assigned (510(k); IDE & IDE Supplements; PMA Supplements, notification of change, etc.)
Direct interface with the Regulatory Agencies on assigned projects.
Perform regulatory assessments of changes as part of the change management process.
Work daily with a high level of integrity and promote a diverse and inclusive workplace culture in both people and thought leadership that is consistent with LivaNova values.
Skills and Experience
Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements.
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.
Education
Minimum of a master’s degree in biomedical engineering, science or equivalent technical discipline and 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
Location & Travel Requirements
This is a remote role (candidates must be based in the United States)
Occasional travel may be required ~10
Pay Transparency
A reasonable estimate of the annual base salary for this position is $85,000 - $95,000 plus discretionary annual bonus. Pay ranges may vary by location.
Employee benefits include:
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
Welcome to impact. Welcome to innovation. Welcome to your new life.
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