LivaNova

Regulatory & Clinical Specialist

Remote, Texas, United States of America · Mid

Sponsorship not specified$85k-$95kDetected 61 days ago

FDA RegulatoryProblem Solving

About the role

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.
Conduct systematic literature searches, appraisal, analysis, and summarization of data for state-of-the-art, safety and performance periodically.

Maintains a continued awareness and understanding of EU and FDA regulations and guidance documents.
Perform regulatory assessments of changes as part of the change management process.
Skills and Experience Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements.
Proven abilities in demonstrating good judgment, building effective working relationships, excellent problem-solving skills.

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.
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.
Expertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature databases.
Medical writing experience with US and EU regulatory requirements understanding in medical device.
Employee benefits include:

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.

This listing is sourced directly from LivaNova's careers page and normalized into a canonical job model.