Clinical Evaluation Lead

About the Role Lead the generation and development of Clinical Evaluation Reports (CER) and PMCF-related documentation for Getinge's Maquet Cardiovascular. You will synthesize clinical data, perform literature reviews, ensure alignment with MEDDEV 2.7/1 Rev 4 and EU MDR, and contribute to the Summary of Safety and Clinical Performance. This fixed-term, remote/hybrid role is US-based (EST preferred) with potential to convert to regular hire. What You'll Do

• Serve as clinical evaluation lead on CERs and PMCF, planning literature reviews and data analysis in line with EU MDR and MEDDEV 2.7/1 Rev 4.
• Contribute to Summaries of Safety and Clinical Performance.
• Participate in PMCF team; conduct literature reviews and data analysis for PMCF evaluation.
• Perform comprehensive systematic literature reviews using PubMed, Embase, and other engines; support Clinical Evaluation, PMCF, protocol development, ad hoc reports.
• Analyze clinical evidence to support Clinical Affairs strategy.
• Write/edit clinical study documentation: clinical investigation plans/protocols, Investigator’s Brochures, Periodic reports, Clinical Study Reports; ensure submission-ready documents.
• Serve as SME on clinical aspects of Technical documentation; support manuscripts for journals; coordinate with medical professionals for journals' requirements.
• Prepare abstracts and submissions for medical congresses; ensure data integrity and high quality submissions.
• Contribute to development/optimization of Clinical Affairs SOPs.
• Other non-routine duties as assigned. What We're Looking For
• Bachelor’s degree in a relevant scientific discipline or equivalent.
• Minimum 3 years medical writing experience; direct experience in clinical evaluations within the Medical Device industry (preferred).
• Medical writing certification (preferred).
• Strong attention to detail, ability to own and drive accuracy.
• Excellent interpersonal, oral and written communication; strong project management skills; ability to deliver on timelines.
• Proficiency with PubMed, Embase; experience with DistillerSR, EndNote (a plus).
• Knowledge of EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV 2.7/1 Rev 4 and 2.12/2 Rev 2, MDCG guidance, ISO 14155, ICH E3, E6 (R3) GCP; familiarity with risk management standards ISO 13485 and ISO 14971.
• Ability to work independently and as part of a team; interact with physicians professionally; prioritize tasks in a fast-paced environment; meet urgent deadlines.
• Advanced Microsoft Office products (Outlook, Word, Excel, PowerPoint).
• Travel as project demands. Nice to Have
• Medical writing certification (additional).
• Experience with regulatory submissions and journal manuscript preparation. Compensation & Benefits
• Salary: $105,000—$115,000 per year; 10% STI.
• Benefits include Health, Dental, Vision; 401(k) with company match; Paid Time Off; Wellness initiative & Health Assistance Resources; Life Insurance; Short- and Long-Term Disability; Health and Dependent Care Flexible Spending.