When you’re working Regulatory Affairs Manager jobs, Regulatory Affairs Director jobs, as a Regulatory Affairs Manager, Senior Regulatory Affairs Manager, or Regulatory Affairs Project Manager, you’ll take on the role of diligently monitoring your company or organization’s production activities to ensure compliance with various applicable regulations and standard operating procedures. In Regulatory Affairs Manager jobs, you’ll oversee regulatory submissions, making sure they accurately and completely comply with regulations dictated by government bodies and other entities. You’ll prepare and file the submission documents and assist with external audits to ensure compliance. You will also respond to any potential complaints regarding devices and products. Finally, you’ll manage a team or teams who will assist you in achieving any and all regulatory endeavors by monitoring their performance and output to ensure your company or organization’s continued success.

Regulatory Affairs Manager Roles and Responsibilities

• Prepare and file regulatory submissions.
• Perform assessments of new or revised products to ensure compliance. 
• Manage complaint documentation if and when complaints arise.
• Perform or facilitate audits to ensure compliance.
• Respond to enquiries from regulatory bodies regarding products and devices.
• Improve internal processes to reduce risk and identify potential issues before they become detrimental to your company or organization’s quality efficiency.
• Collaborate with team members to obtain appropriate and accurate documentation as needed.

Regulatory Affairs Manager Skills and Qualifications

• A bachelor’s degree in a technical field relevant to your position
• Organizational skills
• Communication skills
• Regulatory experience in the industry commensurate with position requirements or desires
• Up-to-date knowledge of international and governmental guidelines
• Diligent attention to detail