Livanova
Regulatory & Clinical Specialist
US_Remote, USA
Sponsorship not specified$85k-$95kDetected 15 days ago
NegotiationFDA RegulatoryMedical DevicesCollaborationProblem SolvingRegulatory Affairs
About the role
- Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future.
- If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive.
- Notice to third party agencies: Please note that we do not accept unsolicited resumes from recruiters or employment agencies.
Responsibilities
- Support the Compliance Review Board process by reviewing promotional materials for compliance with applicable regional regulation as the Regulatory representative.
- Maintains a continued awareness and understanding of EU and FDA regulations and guidance documents.
- Perform regulatory assessments of changes as part of the change management process.
- Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements.
Skills
- Expertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature databases.
- 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.
- This is a remote role (candidates must be based in the United States)
- Occasional travel may be required ~10
- Health benefits - Medical, Dental, Vision
- Personal and Vacation Time
Compensation
- A reasonable estimate of the annual base salary for this position is $85,000 - $95,000 plus discretionary annual bonus.
- Pay ranges may vary by location.
- In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee.
Benefits
- Author, prepare and/or update clinical evaluation plans (CEP) and reports (CER) for active implantable medical devices/systems in accordance with EU MDR requirements.
Company info
- LivaNova values equality and diversity.
- We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.
- Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.
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