Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

The Regulatory and Clinical Specialist will support clinical evaluation activities, review promotional materials, and support regulatory submissions for active implantable medical devices within the Neuromodulation Business Unit. This role serves as a liaison, collaborating with various internal groups to ensure deliverables meet project deadlines and 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, review initiation, discussion of revisions, and document completion.
• Respond to regulatory authority queries regarding clinical evaluation.
• Support the Compliance Review Board process by reviewing promotional materials for compliance with applicable regional regulations.
• Maintain awareness and understanding of EU and FDA regulations and guidance documents.
• Prepare assigned regulatory submissions (e.g., 510(k), IDE & IDE Supplements, PMA Supplements, notification of change).
• Serve as 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 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 an understanding of US and EU regulatory requirements for medical devices.
• Class III active-implantable experience is 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, and excellent problem-solving skills.

Skills

• Clinical Evaluation Plans
• Clinical Evaluation Reports
• EU MDR
• EU MDD
• Literature Searches
• PubMed
• Embase
• MedLine
• Regulatory Submissions
• FDA PMA applications
• IDE Progress Reports
• Technical Files
• Medical Writing
• US Regulatory Requirements
• EU Regulatory Requirements
• Medical Device
• Negotiation
• Conflict Resolution
• Problem-Solving

Location

• Remote (United States)

Work Type

• Remote
• Full-time

Experience Level

• 5 years of previous related experience in medical writing and medical device regulatory affairs (with Master's degree)
• 3 years of experience (with Ph.D.)

Education Level

• Master's degree in biomedical engineering, science, or equivalent technical discipline
• Ph.D.

Salary/Compensations

• $85,000 - $95,000 plus discretionary annual bonus

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

About the Company

• LivaNova is a global medtech company driven by a Vision of changing the trajectory of lives for a new day and a Mission to create ingenious solutions that ignite patient turnarounds.
• The company has a relentless commitment to patients and a strong legacy of innovation in healthcare.
• LivaNova aims to be a pioneer of tomorrow, altering the course of lives by treating conditions.
• The company treats its work as if lives depend on it, with employees committed to making the world a better place.
• The team's commitment to improving quality of life embodies the company's Vision and Mission.

Equal Opportunity

• Promote a diverse and inclusive workplace culture in both people and thought leadership that is consistent with LivaNova values.