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Responsibilities
1. Manage the clinical evaluation of our products for their release and launch to the global market.
a. Manage and perform gap analysis for new product clinical performance and advise project team on clinical evaluation requirements
b. Responsible for the evaluation of clinical data for new product clinical evaluations.
c. Responsible for post-market clinical follow up plan and strategy.
2. Responsible for the clinical lifecycle throughout the lifecycle of SSMR product portfolio.
a. Continuously monitor and verify the device’s clinical performance and safety as part of post-market clinical follow up
3. Responsible for the Clinical Evaluation and Clinical Lifecyle Management process according to Medical Device Regulation and NMPA regulations. Working closely with counterparts in Erlangen and quality department to establish a harmonized process.
4. Post market clinical follow up process at SSMR and will work closely with project teams in SSMR and counterparts in Erlangen.
5. Responsible for the product Survey and Analysis report of SSMR products to ensure that market feedback is incorporated into our product development.
6. Responsible keeping up to date with latest regulatory body clinical evaluation requirements and standards and incorporating them into our process and lifecycle management
Requirements
-Good level of English language skills both spoken and written
-Qualifications: Clinical / medical degree
-Knowledge of regulatory requirements (EC DoC and NMPA highly desirable)
-Strong communication skills bringing stakeholders and 3rd party together to perform the clinical evaluation and management
-Good organizational and leadership qualities
-Proactive "getting things done" attitude
-Experience of liaising with medical opinion-leaders, specialist associations, funding bodies and politicians, ideally having a network within relevant specialist committees (highly desirable).
-Highly results-oriented with a growth mindset. Capable of presenting action to management and/or customers.
-Work experience within a multidisciplinary and multicultural environment (highly desirable).