Remote Regulatory & Clinical Specialist, MedTech

LivaNova; Minneapolis (MN); 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, regulatory submissions, and maintain compliance for active implantable devices. Candidates must have a minimum of a master's degree and experience in medical writing and regulatory affairs.

This remote role requires occasional travel and offers an annual salary of $85,000 - $95,000, along with benefits like health insurance and a 401K plan.

Qualifications

• Minimum of 5 years of experience in medical writing and regulatory affairs.
• Understanding of medical device regulatory requirements in the US and EU.

Responsibilities

• Prepare and update clinical evaluation plans and reports.
• Conduct systematic literature searches and analysis.
• Manage document development process according to timelines.
• Responsible for regulatory queries and compliance.
• Prepare regulatory submissions and interface with regulatory agencies.

Skills

Writing Clinical Evaluation Plans and Reports (CEP, CER)

Conducting literature searches

Development of regulatory submissions

Medical writing experience

Negotiation and conflict resolution

Rapid learning of new therapeutic areas

Good judgment and problem-solving skills

Education

Master's degree in biomedical engineering or related field

Ph.D. with experience in medical writing

Job description

LivaNova is seeking a Regulatory and Clinical Specialist to support clinical evaluations, regulatory submissions, and maintain compliance for active implantable devices. Candidates must have a minimum of a master's degree and experience in medical writing and regulatory affairs.

This remote role requires occasional travel and offers an annual salary of $85,000 - $95,000, along with benefits like health insurance and a 401K plan.