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Key responsibilities and accountabilities

Participate in multidisciplinary teams and communicate regulatory requirements
Support and prepare all regulatory submissions for clinical investigations and product registration in US, EU or other countries
Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.
Support compilation and submission of technical documentations, change notification and/or renewal application of Nextkidney products
Participate and represent regulatory affairs during FDA and NB site audits
Reviews protocols and reports to support regulatory submissions
Review labelling/marketing materials for regulatory compliance
Respond to questions from regulatory authorities within strict timelines
Support and Review SOPs

Education and experience

Minimum of a Bachelor’s Degree in a scientific field such as Science, Pharmacy or Engineering
5+ years of experience working with medical devices and its associated regulations
Experience in sterile and non-active device is a plus
Experience in programmable electrical medical systems is a plus
Experience in compiling and submitting medical device applications particularly in Europe and US
Excellent verbal and written communication skills in English and French
Interpersonal and communication skills
Highly developed attention to detail