Clinical Evaluator (CER Writer)

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Location : 100% remote work

Salary : 15 300 – 17 000 PLN gross per month (temporary employment contract via Experis)

Tasks :

• Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans / Reports, PMS and PMCF Plans / Reports, SSCPs, Regulatory Responses and other related documentation
• Effectively communicates and collaborates with global R&D, Regulatory Affairs, Library Services, Quality, Clinical Affairs, and Risk Management teams in completing clinical evaluation project deliverables and publication reviews
• Maintains thorough knowledge of assigned products and identifies appropriate sources of relevant data
• Interprets, evaluates and incorporates information from literature, clinical data and medical references
• Manages document control and reviewers for CERs
• Ensures quality, consistency and integrity of data in all deliverables
• Ensures compliance with applicable regulations and guidance documents including ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, EU and FDA guidance documents and applicable SOPs
• Demonstrates understanding of clinical background and state of the art, literature review and search strategy, article processing and synthesis, MAUDE search and safety database summary, internal clinical trial results and clinicaltrials.gov search
• Integrates and interprets competitor data, sales and complaints analysis, vigilance summary, risk / benefit evaluation, claims matrix analysis, field actions, CAPAs, recalls, mitigations, references, appendices and QC processes with MD Reviewer and Notified Bodies
• Maintains CER SOP for current MDR regulatory requirements
• Supports research for Post Market Surveillance Reports

Requirements :

Offer :

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Experis to światowy lider rekrutacji specjalistów i kadry zarządzającej w kluczowych obszarach IT. Z nami znajdziesz konkurencyjne oferty zatrudnienia oraz ciekawe projekty IT skierowane zarówno do ekspertów z wieloletnim doświadczeniem, jak i osób, które dopiero zaczynają swoją przygodę w branży IT.job-detail-footer