(Senior) Clinical Research & Evaluation Specialist, CV

Our client is a well-known medical device company with global presence, focusing on cardiovascular surgery products and systems. They are now seeking for a (Senior) Clinical Research & Evaluation Specialist to join the clinical team.

Key Responsibilities:

• Develop literature search protocols and search strategies
• Critical analysis of published literature for validity, reliability, and scientific credibility; conduct literature reviews and deliver literature search results and reference citations to the team, stay up-to-date on the latest scientific and medical developments
• Prepare and review regulatory documents and response to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs) and associated documents (CEP, PMCFR, PMCFP, etc)
• Participates in the Clinical Evaluation and Post-Market Clinical Follow-up (PMCF), awareness of current State of the Art as well as protocol development and any ad hoc reports required
• Performed literature screening, analysis, appraisal, and weighting of data for relevancy and comprehensive analysis
• Specifically contributes to the literature review and the identification and analysis of clinical data, perform comprehensive systematic, documented literature reviews using various search engines
• Summarize relevant literature and integrate with new or existing information to satisfactorily meet the EU MDR requirements for Clinical Evaluation Reports
• Combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, and EU MDR 2017/745
• Work with the project team leader to ensure the assigned tasks are done on time and within budget
• Maintain responsibility for assigned projects: meeting deadlines, communicating project status to internal teams and project manager, and completing work according to project requirements.

Key Requirements:

• BSc/ MSc/Ph.D./Pharm.D. in Biological/ Biomedical/ Biotechnology/ Bioengineering or in related disciplines
• 1 to 5 years of related experience in pharmaceutical/ medical device industry, with a deep understanding of research design, methodology, and statistic; Has previous experience in writing Clinical Evaluation Reports (CERs) and related documents in accordance with MEDDEV 2.7/1 rev 4 and EU MDR Regulations
• Experienced in regulatory submission, clinical trial, and marketing approval of medical devices is preferred
• Fresh graduates with 1 to 3 years of relevant scientific/ academic/ clinical regulatory searching experience (e.g., medical writing, clinical research) are welcome
• Candidate from sizeable CRO who has experience in overseeing worldwide clinical projects are welcome
• Excellent command / highly proficient in spoken and written English
• Possesses strong command of medical and surgical terminology and demonstrates effective written, verbal and presentation skills in the area of technical/clinical applications
• Demonstrated independent execution of systematic literature reviews of available therapeutic or diagnostic treatment options, including search and selection, extraction, synthesis, and structured written presentation of data
• Being independent and being able to work under pressure, self-motivated, with good problem-solving skills and goal-focused, also being a good team player