What You’ll Do Qserve 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.
Tasks & responsibilities:
Plan deliverables, deadlines and ensure those are well‑communicated and performed on time.
Recommend the best strategy to be used for the clinical evaluation considering regulatory requirements, device claims and available clinical data.
Set clinical outcome parameters and acceptance criteria to support the clinical claims of the devices.
Perform 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.
Elaborate, update and peer review Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs) and Literature Search Reports (LSRs).
Write state‑of‑the‑art (SOTA) text based on selected data.
Ensure that peer review of any documentation is performed internally prior to delivery to the client.
Answer questions from Regulatory Authorities regarding clinical evaluation.
Provide 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.
Ensure customer satisfaction, adherence to Qserve and customer policies and procedures in the conduct of work.
What You’ll Bring To The Team
Technical or scientific degree (BSc, MSc, or Ph.D.) in biomedical engineering, biomedical science, biology, or similar.
At least 4 years of experience in clinical evaluation of medical devices (EU‑MDD and EU‑MDR) in industry, consultancy, or Notified Body roles.
Hands‑on experience with systematic literature search design and appraisal of medical devices.
Familiarity with ISO 13485 and medical device Quality Management Systems.
Experience on post‑market clinical follow‑up (PMCF) and Summary of Safety and Clinical Performance (SSCP) are considered advantages.
Pragmatic approach and ability to manage multiple projects simultaneously.
Excellent communication skills in English.
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