Key skills
Change ManagementNegotiation
About this role
Role Overview
- 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