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