Jose Evers - Senior Manager Resume Simple
SUMMARY
To obtain a position in the health care industry that will allow me to utilize my skills and experience to provide quality patient care. I am a highly motivated individual with a strong background in the healthcare field.
SKILLS
  • management, fda, product development, communications, clinical
  • fda, liaison
WORK EXPERIENCES
  • 2017-12-252017-12-25

    Senior Manager

    Universal Orlando Resort

    • Collaborate with management and clinical team to develop and implement new product development strategy. Ensure that all regulatory submissions are current and current.
    • Conduct regulatory review of promotional materials and ensure that all FDA and regulatory requirements are met and are compliant with current regulations and guidelines.
    • Manage communications with external vendors and partners to ensure timely and accurate responses to regulatory requirements. Review and approve regulatory documents for submission to the FDA.
    • Serve as a liaison between the clinical research department and the regulatory Affairs department. Ensure that the regulatory documents are in compliance with the FDA and other applicable regulations.
    • Manage and maintain regulatory documents and regulatory submissions for submission to the FDA. Provide guidance to the project team on the development of the project.
    • Develop, implement, and maintain the quality assurance and control system (SOPs) for the clinical trial. Perform the development of the regulatory document and ensure compliance with applicable regulations.
  • 2017-12-252017-12-25

    Regulatory Affairs Manager

    The City University of New York

    • Liaison with FDA and other regulatory bodies. Ensure that all regulatory submissions are met. And maintain the integrity of the data.
    • Develop and maintain a tracking system for the regulatory submissions. Ensure that all regulatory documents are submitted to the FDA.
    • Assist in the development of regulatory documents for submission to the FDA. Review and approve regulatory submissions for submission to the FDA.
    • Develop and implement new product labeling and packaging systems. Create and maintain regulatory documents. Provide input to Otsuka Canada.
    • Led the development of a new product development system for the company. This included the creation of a new product line for the market.

 Oasis 

 Dynamic Solutions USA, Inc.