Regulatory and Clinical Specialist

LivaNova

Regulatory and Clinical Specialist at LivaNova supporting clinical evaluation and regulatory submissions for active implantable devices. Collaborating across teams ensuring compliance with EU and FDA regulations.

Posted 5/23/2026full-timeRemote • Colorado, Illinois, Texas • 🇺🇸 United StatesMid-LevelSenior💰 $85,000 - $95,000 per yearWebsite

About the role

Key responsibilities & impact

Support the clinical evaluation activities
Review promotional materials and support regulatory submissions for active implantable medical devices for the Neuromodulation Business Unit
Author, prepare and/or update clinical evaluation plans (CEP) and reports (CER) for active implantable medical devices/systems in accordance with EU MDR requirements
Conduct systematic literature searches, appraisal, analysis, and summarization of data for state-of-the-art, safety and performance periodically
Manage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines
Responsible for regulatory authority queries on clinical evaluation
Prepare regulatory submissions assigned (510(k); IDE & IDE Supplements; PMA Supplements, notification of change, etc.)
Direct interface with Regulatory Agencies on assigned projects
Perform regulatory assessments of changes as part of the change management process
Promote a diverse and inclusive workplace culture in alignment with LivaNova values

Requirements

What you’ll need

Minimum of a master’s degree in biomedical engineering, science or equivalent technical discipline
At least 5 years of previous related experience in medical writing and medical device regulatory affairs or a Ph.D. with at least 3 years of experience
Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively)
Expertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature databases
Demonstrated experience in the development, writing and editing of regulatory/ clinical submissions (e.g. FDA PMA applications, IDE Progress Reports, technical files)
Medical writing experience with US and EU regulatory requirements understanding in medical device
Class III active-implantable experience, preferred
Demonstrates negotiation and conflict resolution skills
Demonstrates ability to rapidly learn new therapeutic areas
Proven abilities in demonstrating good judgment, building effective working relationships, excellent problem-solving skills.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical evaluation plansclinical evaluation reportsregulatory submissionsliterature searchesmedical writingregulatory assessmentsFDA PMA applicationsIDE Progress Reportstechnical filesEU MDR requirements

Soft Skills

negotiation skillsconflict resolution skillsproblem-solving skillsgood judgmentbuilding effective working relationshipsability to learn new therapeutic areasorganizational skillscommunication skillstime managementteam collaboration

Certifications

master’s degree in biomedical engineeringPh.D. in related field