Ph3What You’ll Do /h3 pQserve is seeking a Consultant Clinical Affairs with strong medical writing skills and expertise in systematic literature searching and clinical evaluation of medical devices. In this role, you will support clients in navigating complex regulatory landscapes for devices of different risk classes. You will work closely with global experts to ensure compliance and market access for multiple solutions in healthcare. /p h3Tasks responsibilities: /h3 ul liPlan deliverables, deadlines and ensure those are well‑communicated and performed on time. /li liRecommend the best strategy to be used for the clinical evaluation considering regulatory requirements, device claims and available clinical data. /li liSet clinical outcome parameters and acceptance criteria to support the clinical claims of the devices. /li liPerform design and appraisal of systematic literature searches on multiple databases (PubMed, Science Direct, ClinicalTrials and others), including adverse event ones, such as MAUDE, FDA Medical Device Recalls and similar. /li liElaborate, update and peer review Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs) and Literature Search Reports (LSRs). /li liWrite state‑of‑the‑art (SOTA) text based on selected data. /li liEnsure that peer review of any documentation is performed internally prior to delivery to the client. /li liAnswer questions from Regulatory Authorities regarding clinical evaluation. /li liProvide strategic advice in relation to all aspects of compliance, including the relationship with and/or take part in interactions with Notified Bodies, Certification Bodies and/or National Authorities. /li liEnsure customer satisfaction, adherence to Qserve and customer policies and procedures in the conduct of work. /li /ul h3What You’ll Bring To The Team /h3 ul liTechnical or scientific degree (BSc, MSc, or Ph.D.) in biomedical engineering, biomedical science, biology, or similar. /li liAt least 4 years of experience in clinical evaluation of medical devices (EU‑MDD and EU‑MDR) in industry, consultancy, or Notified Body roles. /li liHands‑on experience with systematic literature search design and appraisal of medical devices. /li liFamiliarity with ISO 13485 and medical device Quality Management Systems. /li liExperience on post‑market clinical follow‑up (PMCF) and Summary of Safety and Clinical Performance (SSCP) are considered advantages. /li liPragmatic approach and ability to manage multiple projects simultaneously. /li liExcellent communication skills in English. /li /ul /p #J-18808-Ljbffr