Our client, in the Life Science / Biotechnology industry, is seeking a Senior Regulatory Specialist. This role will provide direct support to the preparation and submission of IVD device authorizations to regulatory agencies including US FDA, Health Canada, Notified Body, Authorized Representative, and others.

Core Job Responsibilities

• Support Lead Regulatory Authors to prepare and author regulatory submission content for FDA EUA, FDA De Novo, Health Canada Interim Order, CE Marking documentation and other market authorizations as assigned

• Coordinate the preparation and delivery of key submission technical content with SME owners to ensure deliverables meet the requirements of the applicable submission(s)

• Support or engage in interaction with regulatory agencies to submit applications

• Support or lead the evaluation and preparation of responses to regulatory agencies related to submissions.

• Prepare technical files in accordance with applicable EU directives

• Support labeling and marketing materials created with Regulatory input and review to ensure labeling, including product labeling and marketing information, adhere to regulatory requirements. Support global labeling requirements UDI and related required systems such as GUDID, EUDAMED, etc.

   

  Other Responsibilities

• Performs other duties as required or assigned to enable effective functioning of the Regulatory Affairs and Clinical Affairs departments.

   

  Requirements

• Education: B.S. degree in Life Science, Engineering, or related discipline.

• Experience:
• Training: Familiar with MS Office Suite, and web-hosted applications. Good organizational, writing, and verbal communication skills.
•  5+ years of medical device experience in a regulatory affairs role.
• Experience in regulatory submittals and applications.
• Experience in molecular biology products or diagnostic products or IVD