Regulatory Affairs Specialist
Prepare and submit regulatory applications to international agencies.
Description
Manage preparation, submission, and maintenance of regulatory applications to multiple agencies (FDA, Health Canada, NMPA, TGA, HSA, EMA)
Work closely with MI's Clinical Safety Officer, Chief Scientist, Clinical Trial Coordinator, and specialised regulatory consultants
Assist the product team in ensuring product development standard operating procedures are in-line with regulatory requirements
Assist the design team in ensuring all medical products adhere to regulatory requirements
Cultural Commitments
Passion for data-driven excellence
Unshakable integrity as required to work in healthcare
Commitment to a transparent idea meritocracy
Requirements
Written and spoken fluency in English
Secondary education in sciences, healthcare, policy, or legal
Minimum one year working experience
Attention to detail and flair for compliance/logistics
Recommended Assets
Previous experience with regulatory submissions and/or clinical trial design and/or legal affairs
Logistics
Full time, starting 23Q1
Compensation relative to experience, with potential for options
Working remotely in a similar time zone
To apply
Send a letter of interest and your CV by email to mi@mobiointeractive.com with the subject header "MI RAS 2023"
Effective and accessible healthcare for every human.