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The Clinical Evidence Evaluation Specialist specializes in performing ongoing literature searches on LivaNova's medical devices. The Clinical Evidence Evaluation Specialist plans literature search strategies to identify current published information which relates to product clinical benefits, performance, and safety aspects. The Clinical Evidence Evaluation Specialist assesses and reviews relevant articles and extracts relevant outcome data. The Clinical Evidence Evaluation Specialist also maintains the company's electronic medical library and literature search system.

The Clinical Evidence Evaluation Specialist also prepares clinical evaluation plans (CEP) and reports (CER), Post Market Clinical Follow-up (PMCF) Plans and Reports, and performing ad hoc and systematic literature reviews for Post Market Surveillance (PMS) reports.

Essential Job Functions :

1. Perform ad hoc and systematic literature searches on global scientific newly released data to support Product Market Surveillance reports, Global Signal Detection meetings, Study Design Protocols, Global Market Value Dossiers, Regulatory Dossiers, Medical Affairs scientific summary documents.
2. Author and/or update clinical evaluation plans (CEP) and reports (CER) and Post Market Clinical Follow-up (PMCF) Plans and Reports per each product family within the Cardiopulmonary business unit in cooperation with all main internal and external stakeholders within the agreed timelines.
3. Conduct systematic literature reviews and in-depth analysis of clinical and post-market data to validate safety, performance, and clinical benefit.
4. Develop and update State of the Art (SoTA) analyses to reflect medical and scientific advancements.
5. Collaborate with Regulatory Affairs, Device Development, and other teams to ensure alignment on clinical evidence requirements for successful regulatory submissions.

Knowledge, skills and abilities required :

Proficiency in MS Office and IT systems.

Demonstrated ability to analyse clinical, regulatory, and scientific data critically, and foster a culture of continuous improvement.

Previous experience in publication writing. Understanding of the impact factor and relevance of scientific journals and papers.

Industry experience that includes the understanding of Clinical Development, Regulatory Affairs and Marketing activities, through different stages. Understanding of the international guidelines, US and European.

Ability to work well with a diverse group of personalities, team player, flexible and adaptable; ability to build relationships, both internally and externally to the organization. Ability to work independently.

Excellent English oral and written (C2); excellent oral communication and medical writing skills.

Familiarity with industry-wide good publication practices.

Attention to detail, good time management, and critical thinking.

Experience with Distiller, Endnote, literature search platforms or similar.

Education :

Minimum of Bachelors (4 year university) degree. Graduate degree preferred.

Biomedical, medical, or pharmaceutical degree is preferred, or a strong expertise in medical devices.

Experience :

Minimum of 3 years of documented experience in clinical evaluations and PMCF for medical devices and/or other experience in areas such as scientific, medical, or clinical research activities (eg, clinical research, systemic literature reviews, medical writing, publication writing experience, critical assessments of published literature, etc.)

Expertise in clinical regulations for medical devices for major global markets, including US and EU [MDR and MDCG guidelines].

Strong track record in managing complex projects and contributing to innovation within clinical or regulatory fields.

Willingness to travel: up to 25% of the job may be travel

Our commitment to Diversity & Inclusion:

LivaNova values equality and celebrates 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.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.