Clinical Evaluation Lead

About the Role

Join Getinge's Maquet Cardiovascular LLC as a Clinical Evaluation Lead responsible for the generation and development of documents relating to clinical evaluations and investigations, CERs, PMCF, and regulatory-aligned evidence. The role can be hybrid or fully remote in the US (EST preferred) with potential to convert to a regular hire. What You'll Do

• Serve as clinical evaluation lead and participate within the clinical evaluation team for the development and generation of Clinical Evaluation Reports (CER) and associated documentation.

• Plan, conduct literature reviews, and identify, appraise and analyze clinical data in accordance with MEDDEV 2.7/1 Rev 4 and EU MDR; contribute to the Summary of Safety and Clinical Performance.

• Participate in the Post-Market Clinical Follow-Up (PMCF) team; perform literature reviews and analyses for PMCF.

• Conduct comprehensive systematic literature reviews to support Clinical Evaluation, PMCF, state of the art awareness, protocol development, and ad hoc reports.

• Analyze available clinical evidence to support clinical development strategy.

• Write/edit clinical study documentation (clinical investigation plans/protocols, Investigator’s Brochures, periodic reports, Clinical Study Reports) and ensure submission-ready quality.

• Serve as a subject matter expert on clinical aspects of technical documentation.

• Write or support manuscripts for submission to peer-reviewed journals and coordinate with medical professionals to meet journal requirements; develop abstracts and submissions for medical congresses; ensure data integrity. What We're Looking For

• Experience with clinical evaluations, CERs, PMCF, and regulatory alignment with EU MDR and MEDDEV 2.7/1 Rev 4.

• Strong ability to conduct literature reviews and analyze clinical data to inform strategy.

• Proven track record drafting clinical study documentation (plans/protocols, Investigator’s Brochures, periodic reports, CSRs).

• Experience preparing manuscripts for peer-reviewed journals and coordinating with clinicians for journal specifications.

• Experience writing abstracts and submitting to medical congresses; strong focus on data integrity and cross-functional collaboration.

• Excellent written and verbal communication and ability to manage complex documentation in a regulated setting. Compensation & Benefits

• Salary range: $105,000 - $115,000; 10% STI.

• Remote work: fully remote in the US; EST preferred.