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

• Compensation relative to experience, with potential for options
• Working remotely

To apply

• Please review our Culture Document because we adhere to these principles to the letter
• Send a letter of interest and your CV by email to mi@mobiointeractive.com with the subject header "MI RAS"