Regulatory and Clinical Specialist

This is a fully remote position, open to applicants in Colorado, +2 more states.

📋 Description

• Assist in the clinical evaluation processes.

• Evaluate promotional materials and aid in regulatory submissions for active implantable medical devices within the Neuromodulation Business Unit.

• Draft, prepare, and/or revise clinical evaluation plans (CEP) and clinical evaluation reports (CER) for active implantable medical devices/systems in compliance with EU MDR standards.

• Execute systematic literature reviews, assessment, analysis, and summarization of data pertaining to state-of-the-art, safety, and performance on a periodic basis.

• Oversee the development and approval workflow for assigned documents (CEP, CER, etc.) while adhering to deadlines.

• Serve as the primary contact for regulatory authority inquiries regarding clinical evaluations.

• Prepare assigned regulatory submissions (510(k); IDE & IDE Supplements; PMA Supplements, notifications of change, etc.).

• Maintain direct communication with Regulatory Agencies on designated projects.

• Conduct regulatory evaluations of changes as part of the change management protocol.

• Foster a diverse and inclusive workplace culture that aligns with LivaNova values.

⛳️ Requirements

• A minimum of a master’s degree in biomedical engineering, science, or a related technical field.

• At least 5 years of relevant experience in medical writing and medical device regulatory affairs, or a Ph.D. with a minimum of 3 years of experience.

• Proficient in writing Clinical Evaluation Plans and Reports (CEP, CER, respectively).

• Skilled in performing targeted literature searches using PubMed, Embase, MedLine, or other comparable medical literature databases.

• Proven experience in the creation, writing, and editing of regulatory and clinical submissions (e.g., FDA PMA applications, IDE Progress Reports, technical documentation).

• Familiarity with US and EU regulatory requirements concerning medical device medical writing.

• Preferred experience with Class III active implantable devices.

• Exhibits strong negotiation and conflict resolution capabilities.

• Ability to quickly acquire knowledge of new therapeutic areas.

• Demonstrated good judgment, ability to build effective working relationships, and 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.