Regulatory & Clinical Specialist
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.
About the role
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. This role acts as a liaison within the organization, collaborating with various groups to communicate and deliver on project deadlines in line 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.
- Respond to regulatory authority queries on clinical evaluation.
- Support the Compliance Review Board process by reviewing promotional materials for compliance with applicable regional regulations as the Regulatory representative.
- Maintain 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.).
- Serve as a direct interface with 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 consistent with LivaNova values.
Requirements
- Experience writing Clinical Evaluation Plans and Reports (CEP, CER) 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 for medical devices.
- Class III active-implantable experience preferred.
- Demonstrates negotiation and conflict resolution skills.
- Ability to rapidly learn new therapeutic areas.
- Proven abilities in demonstrating good judgment, building effective working relationships, and excellent problem-solving skills.
Qualifications
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
- This is a remote role (candidates must be based in the United States).
- Occasional travel may be required (~10%).
Pay
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.
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