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"