Salaire BARRINGTON JAMES

participate in regulatory submissions and support interactions with regulatory authorities during audits and inspections
collaborate with internal stakeholders to ensure accurate and timely compilation of clinical data, including clinical investigation reports, post-market surveillance data, and other relevant sources
ensure compliance with applicable standards and regulations, such as MDR and MEDDEV guidelines, throughout the clinical evaluation process
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monitor and stay updated on relevant regulatory changes and industry best practices related to clinical evaluation and evidence requirements
collaborate with external partners, such as clinical experts and consultants, to enhance the clinical evaluation process and leverage their expertise when needed

strong analytical skills, with the ability to critically review and interpret clinical data and scientific literature
proficiency in conducting systematic literature reviews and performing statistical analysis
excellent communication skills, both written and verbal, with the ability to effectively present complex scientific information to diverse audiences
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proven ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously
bachelor's or Master's degree in a relevant scientific discipline . A Ph.D. is a plus
detail-oriented mindset with strong organizational and problem-solving skills
solid experience in clinical evaluation report writing and clinical evaluation planning within the medical device industry, preferably in the field of ultrasound
proficiency in relevant software and tools for data analysis, literature review, and documentation
in-depth knowledge of applicable regulations, standards, and guidelines, such as MDR, MEDDEV, and ISO 14155, as they pertain to clinical evaluation and evidence requirements
fluency in English is required. Additional language skills, particularly French, are beneficial

BARRINGTON JAMES