Remote Regulatory & Clinical Specialist, MedTech

LivaNova; Houston (TX); 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

Flexible Work Schedules

Job summary

LivaNova is seeking a Regulatory and Clinical Specialist to support clinical evaluation activities and regulatory submissions for active medical devices. This remote role emphasizes collaboration with cross-functional teams and ensures compliance with EU MDR and FDA regulations.

The ideal candidate should possess strong medical writing skills and experience in regulatory submissions. The position offers an annual salary between $85,000 - $95,000 along with generous employee benefits including health, retirement, and flexible work schedules.

Qualifications

• 5 years of experience in medical writing and regulatory affairs.
• Experience in EU MDD and MDR requirements.
• Writing and editing experience for regulatory submissions.

Responsibilities

• Prepare clinical evaluation plans and reports.
• Conduct systematic literature searches and analyses.
• Manage approval processes for documents.
• Respond to regulatory authority queries.

Skills

Experience writing Clinical Evaluation Plans and Reports

Expertise in conducting literature searches

Experience in regulatory/clinical submissions

Understanding of US and EU regulatory requirements

Class III active-implantable experience

Negotiation and conflict resolution skills

Ability to rapidly learn new therapeutic areas

Good judgment and problem-solving skills

Education

Master's degree in biomedical engineering or related field

Ph.D. in relevant discipline with experience

Job description

LivaNova is seeking a Regulatory and Clinical Specialist to support clinical evaluation activities and regulatory submissions for active medical devices. This remote role emphasizes collaboration with cross-functional teams and ensures compliance with EU MDR and FDA regulations.

The ideal candidate should possess strong medical writing skills and experience in regulatory submissions. The position offers an annual salary between $85,000 - $95,000 along with generous employee benefits including health, retirement, and flexible work schedules.