Remote Regulatory & Clinical Specialist, MedTech

LivaNova; Charlotte (NC); Remote; USD 85,000 - 95,000; Full time

Benefits offered by this job

Health benefits (Medical, Dental, Vision)

Personal and Vacation Time

401K Retirement & Savings Plan

Employee Stock Purchase Plan

Training & Education Assistance

Bonus Referral Program

Employee Recognition Program

Flexible Work Schedules

Job summary

LivaNova is seeking a Regulatory and Clinical Specialist to support clinical evaluation activities for active implantable medical devices. This role involves writing clinical evaluation plans and reports, managing regulatory submissions, and maintaining compliance with EU and FDA regulations.

The ideal candidate should have a master's degree in biomedical engineering or related field along with 5 years of experience in medical writing and regulatory affairs, or a Ph.D. with 3 years of experience. This position offers a salary range of $85,000 - $95,000, plus benefits and remote work options.

Qualifications

• 5 years of experience in medical writing and regulatory affairs, or 3 years with a Ph.D.
• Expertise in EU MDD and MDR requirements.
• Understanding of US and EU medical device regulations.

Responsibilities

• Author and update clinical evaluation plans and reports.
• Conduct systematic literature searches and summarize data.
• Prepare regulatory submissions and manage development timelines.
• Maintain awareness of EU and FDA regulations.

Skills

Clinical Evaluation Plans writing

Literature searches expertise

Regulatory submissions development

Medical writing experience

Class III active-implantable experience

Conflict resolution skills

Education

Master's degree in biomedical engineering or Ph.D.

Job description

LivaNova is seeking a Regulatory and Clinical Specialist to support clinical evaluation activities for active implantable medical devices. This role involves writing clinical evaluation plans and reports, managing regulatory submissions, and maintaining compliance with EU and FDA regulations.

The ideal candidate should have a master's degree in biomedical engineering or related field along with 5 years of experience in medical writing and regulatory affairs, or a Ph.D. with 3 years of experience. This position offers a salary range of $85,000 - $95,000, plus benefits and remote work options.