Senior Regulatory Affairs Manager

6 days ago


Étreux, Hauts-de-France, United States Jobot Full time
Job Summary

We are seeking a highly experienced Regulatory Affairs Manager to join our team at Jobot, a leading consulting firm in the medical device industry.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with FDA and other relevant regulatory requirements.
  • Manage quality assurance processes, including audits, corrective actions, and quality control systems.
  • Lead a team of regulatory professionals, providing guidance and support for their continued development and success.
  • Liaise with regulatory bodies and external stakeholders on all regulatory matters.
  • Review and approve regulatory submissions to ensure accuracy and completeness.
Requirements:
  • A bachelor's degree in a scientific discipline; an advanced degree is preferred.
  • A minimum of 3-5 years of experience in regulatory affairs in the medical device industry, including experience with FDA regulations.
  • Proven leadership skills with experience managing a small team.
  • Excellent knowledge of regulatory requirements and quality assurance principles.
About Us

We offer a competitive salary package of $100,000 - $125,000 per year, depending on experience. This includes a comprehensive benefits package, opportunities for growth and development, and a chance to work in multiple therapeutic areas.



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