[Remote] Regulatory & Clinical Specialist

Note: The job is a remote job and is open to candidates in USA. LivaNova is a global medtech company focused on innovative healthcare solutions. The Regulatory and Clinical Specialist will support clinical evaluation activities and regulatory submissions for active implantable medical devices, while collaborating with various teams to ensure project deadlines are met in compliance with regulatory requirements.ResponsibilitiesAuthor, prepare and/or update clinical evaluation plans (CEP) and reports (CER) for active implantable medical devices/systems in accordance with EU MDR requirementsConduct systematic literature searches, appraisal, analysis, and summarization of data for state-of-the-art, safety and performance periodicallyManage 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 membersResponsible for regulatory authority queries on clinical evaluationSupport the Compliance Review Board process by reviewing promotional materials for compliance with applicable regional regulation as the Regulatory representativeMaintains a continued awareness and understanding of EU and FDA regulations and guidance documentsPrepare regulatory submissions assigned (510(k); IDE & IDE Supplements; PMA Supplements, notification of change, etc.)Direct interface with the Regulatory Agencies on assigned projectsPerform regulatory assessments of changes as part of the change management processWork 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 valuesSkillsExperience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirementsExpertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature databasesDemonstrated 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 deviceDemonstrates negotiation and conflict resolution skillsDemonstrates ability to rapidly learn new therapeutic areasProven abilities in demonstrating good judgment, building effective working relationships, excellent problem-solving skillsMinimum 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 experienceClass III active-implantable experience, preferredBenefitsHealth benefits – Medical, Dental, VisionPersonal and Vacation TimeRetirement & Savings Plan (401K)Employee Stock Purchase PlanTraining & Education AssistanceBonus Referral ProgramService AwardsEmployee Recognition ProgramFlexible Work SchedulesCompany OverviewLivaNova is a medical technology company that specializes in advanced cardiac surgery, neuromodulation, and circulatory support solutions. It was founded in 1987, and is headquartered in London, England, GBR, with a workforce of 1001-5000 employees. Its website is http://www.livanova.com.