We are seeking a highly skilled and motivated Clinical Scientist to join our Clinical Compliance Team. The successful candidate will play a crucial role in ensuring compliance with regulatory requirements and standards governing products deployment and research. With a focus on clinical biological or physical sciences, the candidate will contribute expertise to drive the development and execution of compliance strategies, ensuring the integrity and quality of our clinical programs prior to deployment as well as during their post market surveillance.

Responsibilities

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

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

• Participate preparation 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

• 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

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

• 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)

• PhD or MSc/Engineering (+2-5 years of experience) in Medical Imaging, Medical Physics, Life Science, Clinical Biological or Physical Sciences (e.g., Clinical Pharmacology, Biochemistry, Molecular Biology, Pharmacology, Chemistry, Biophysics, Engineering with applications in heath sector etc.).

• Experience with medical data (DICOM)

• Demonstrated understanding of regulatory requirements and standards applicable to clinical research (e.g., Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Code of Federal Regulations (CFR), etc.).

• Experience working in a clinical compliance, regulatory affairs, or quality assurance role within the pharmaceutical, biotechnology, or medical device industry is a plus.

• Strong analytical and problem-solving skills, with the ability to critically evaluate complex scientific and regulatory issues.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams and influence stakeholders at all levels.

• Detail-oriented mindset with a commitment to accuracy and data integrity.

• Proven ability to manage multiple priorities and deadlines in a fast-paced, dynamic environment.