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.
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
- 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
- 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
- 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
- Class III active-implantable experience, preferred
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
Company Overview
LivaNova 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.