
- PARTNERS
- …
- PARTNERS
- PARTNERS
- …
- PARTNERS
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"
Effective and accessible healthcare for every human.