Dohmen Life Science Services

  • Regulatory Affairs Manager

    Job Locations US-CO-Wheat Ridge
    Job ID
    2018-2044
    # of Openings
    1
    Category
    Consulting
  • Overview

    OUR COMPANY:

     

    Since 1858, Dohmen has been driven by the desire to get safe and effective treatments and cures to the people that need them most.  As entrepreneurs, we’ve looked for new and better ways of doing this year after year. Today, as Dohmen Life Science Services, we bring the industry’s most comprehensive service array to Medical Device, Biotech and Pharmaceutical entrepreneurs, helping them get farther faster and keeping them focused on innovations that improve lives. 

     

    Our behavior is guided by five simple values –

    Caring: We are empathetic and respectful.  We ask “how can I help you”

    Committed: We are dedicated and persistent.  We ask “how can I make it happen”

    Creative: We are inventive and imaginative. We ask “how can I do it better”

    Collaborative: We are cooperative and share our knowledge. We ask “how can we achieve success” 

    Courageous: We’re willing to risk failure over inaction. We ask “how can I challenge myself”

    This perspective defines us. How we act, how we do business, how we work with our clients and how we work with each other. They are essence of what makes us successful. They are what set us apart. 

     

    THE POSITION 

     

     

    The Manager of Regulatory Affairs will have the responsibility for managing the regulatory aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies. This position will function as a direct contact with regulatory authorities to facilitate the prompt review and approval of submissions. This person will develop appropriate responses to FDA 483s and Warning letters.

     

     

    POSITION SUCCESS FACTORS:

    • Ability to handle technical resources at a variety of levels.
    • Ability to manage multiple projects acros a variety of external clients.

                ESSENTIAL FUNCTIONS:

    • Managing the regulatory aspects of projects, including complex applications submitted to various regulatory agencies.
    • Ensuring that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.
    • Developing strategic regulatory approaches for projects, as appropriate with some oversight.
    • Planning and conducting formal meetings and teleconferences with regulatory authorities.

     

     

    Responsibilities

    RESPONSIBILITIES:

      • Work as Regulatory Affairs Consultant in the regulatory strategy and projects group
      • Managing, training and mentoring regulatory associates and/or quality specialists

       

    Qualifications

    MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

    • Bachelor’s degree in a related discipline with a minimum of 5 years regulatory affairs experience is preferred; medical device industry experience is needed.
    • Master's degree in a related discipline with 2 years regulatory affairs experience is also acceptable.
    • Incumbent must be able to operate in a highly structured environment and manage multiple projects simultaneously while providing options to DLSS clients that work to keep the client in compliance with all appropriate regulations.
    • Experience managing and/or mentoring technical resources is highly desired.

     

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