Responsibilities

•  Designing and leading clinical validation of our products in order to ensure medical device regulation complaince 

• Ensuring integrity and quality of clinical data by implementing rugourous quality checks before usage of the data in any development or testing phase. 

• Participate prepartion of the regulatory document related to performance validation studies. 

Missions:

• Support data curation by ensuring the clinical quality check of the relevant data before its internal usage in development or testing steps 

• Ensure timely data collection (including visits to partners) 

• Design and generate the specific datasets characteristics, with the appropriate size and attributes to meet the usage goals (including statistical evaluation). 

• Create and follow the documentation around data management process and compliance with data regulations such as GDPR 

• Follow up KPIs and report activity. 

• Conduct literature review  

• Design and coordinate clinical validation studies to ensure product compliance with clinical aspects of medical device regulation in EU (MDR 2017/745) and USA. 

• Follow-up and coordination of clinical projects with TheraPanacea internal teams and clinical partners 

• Participate in tasks related to the consolidation of our clinical partnership relationships as part of clinical studies 

• Support in the compilation of abstracts and contribute to scientific publications 

•  Understand clinical workflow and clinical needs 

• Contribute to define clinical needs, contribute to develop solutions in collaboration with other teams. 

• Participate in tasks related to the generation and keeping of technical documents related to Clinical Evaluation and Post-market surveillance of our products (e.g. literature review, design of protocols and surveys, drafting/updates of quality documents, internal marketing watch, etc) Lead sub-projects related to the above activities, e.g. CER project management, follow up of PMCF activities, FDA file submission)

Minimum level required: MSc in Medical Physics

 Language:  French/English

Required skills:

• Medical imaging or medical physics background  

• Understanding clinical data 

• Data management experience is a plus 

• Project management skills 

• Ability to understand clinical workflows and needs 

• Strong analytical, presentation and communication skills 

• Ability to develop strong relationship with customers and users 

• Ability to write scientific protocols, abstract and papers  

• Ability to understand and compile scientific literature  

• Basic understanding of machine learning concepts. An application of these techniques in a medical context would be appreciated.  

• Ability to travel locally and internationally (estimated at max 20%)  

• Experience as contributor in product development is a plus 

• Experience with/training on data regulation and GDPR is a plus 

• Familiarity with coding languages (ie: Python) is a plus 

• Familiarity with Git is a plus 

Regulatory skills:  

• Knowledge in ISO 13485, ISO 6230 is a plus 

• knowledge of regulatory systems (FDA, EU MDR) is a plus

Interview with HR department

Interview with manager