Remote Regulatory & Clinical Specialist (Medical Devices)

LivaNova; Arizona; Remote; USD 85,000 - 95,000; Full time

Benefits offered by this job

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

Job summary

LivaNova is seeking a Regulatory and Clinical Specialist to support clinical evaluations and regulatory submissions for active implantable medical devices. The role requires solid experience in writing evaluation plans and reports, managing documentation processes, and interfacing with regulatory agencies.

This remote position is open to candidates based in the United States, offering a salary estimate of $85,000 - $95,000 plus bonus. Employee benefits include health coverage, retirement plans, and flexible work schedules.

Qualifications

• Experience in writing Clinical Evaluation Plans and Reports (CEP, CER).
• Expertise in literature searches on medical databases.
• Development and editing of regulatory submissions.
• Medical writing experience compliant with US and EU regulations.

Responsibilities

• Prepare clinical evaluation plans and reports according to EU MDR.
• Conduct literature reviews and summarize safety and performance data.
• Manage document development and approval processes.
• Support compliance by reviewing promotional materials.
• Prepare regulatory submissions and interface with Regulatory Agencies.
• Perform regulatory assessments as part of change management.

Skills

Writing Clinical Evaluation Plans and Reports

Conducting literature searches

Medical writing in US and EU

Regulatory submissions development

Negotiation and conflict resolution

Learning new therapeutic areas

Good judgment and problem solving

Education

Master's degree in biomedical engineering or related field

Job description

LivaNova is seeking a Regulatory and Clinical Specialist to support clinical evaluations and regulatory submissions for active implantable medical devices. The role requires solid experience in writing evaluation plans and reports, managing documentation processes, and interfacing with regulatory agencies.

This remote position is open to candidates based in the United States, offering a salary estimate of $85,000 - $95,000 plus bonus. Employee benefits include health coverage, retirement plans, and flexible work schedules.