Regulatory Operations Lead

5 days ago


Boston, Massachusetts, United States Jobot Full time

We are seeking a Regulatory Operations Lead to join our team at Jobot. As a key member of our regulatory affairs department, you will play a critical role in ensuring our organization's compliance with FDA and other relevant regulations.

About the Role

This is an exciting opportunity to lead and manage a team of regulatory professionals, providing guidance and support to ensure their continued development and success.

You will be responsible for overseeing and managing most aspects of regulatory affairs, including developing and implementing regulatory strategies and processes, and liaising with regulatory bodies and other external stakeholders.

The estimated salary for this role is $95,000 - $120,000 per year, depending on location and experience.

Key Responsibilities
  • Lead and manage a team of regulatory professionals, providing guidance and support to ensure their continued development and success.
  • Develop and implement regulatory strategies and processes to ensure compliance with FDA and other relevant regulations.
  • Liaise with regulatory bodies and other external stakeholders, representing the organization in all regulatory matters.
  • Review and approve all regulatory submissions, ensuring their accuracy and completeness.
Requirements

• Bachelor's degree in a scientific discipline

• Minimum 3-5 years of experience in regulatory affairs in the medical device industry, including experience with FDA regulations

• Excellent knowledge of regulatory requirements and quality assurance principles

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