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Recent Production Re Organization Inquiries

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Medical Device Re Registration

Needed: project leader to lead a team of subject matter experts in reviewing and preparing for medical device regulatory re-registration activities at one of our well-established clients.   required skills:  ·        ability to lead a team of subject matter experts.  ·        ability to manage complex regulatory and technical compliance issues.  ·        ability to clearly discern and assess complex regulatory submissions.  ·        experience in leading complex cross-functional projects. ·        robust technical writing skills  tasks: ·        collect and coordinate information for active design dossiers and technical files into the sted format and advise on the submission strategy.  ·        create and maintain product technical files, clinical evaluation reports and regulatory submission dossiers.  ·        review labeling and labels, product codes, legal manufacturers, and classifications for compliance with us and eu requirements.  ·        review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.  ·        review changes to existing products and sops to define the requirements for regulatory submissions. ·        responsibility for timely registrations.    education and experience:  ·        15+ years of experience in regulatory affairs and compliance  ·        leading projects and directing strategies for medical devices, biologics, and/or pharmaceutical  ·        minimum bachelor’s degree in a scientific or technically related field.  ·        knowledge of the global regulatory approval processes and requirements  ·        experience with class ii and ii medical devices is mandatory.  ·        excellent project management skills.  ·        high level of integrity.  ·        strong problem solving and communication skills.

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    Anne |Zintro Expert

    I just wrote you a letter for a medical device Reg affairs position. It looks like this is also with...

    1.2 Hours Later
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    Kenneth |Principal

    Hello Ziafef2ddd Happy New Year. I always find it difficult to write to a a symbolic tie. I am inte...

    2 Hours Later
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    Umberto |Previously: COO, VP & Director Regulator

    Dear Inquirer, I have been *****lved in leading projects, *****tegies, developing...

    2.2 Hours Later
+8 Other Responses
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Cable Re-transmission Agreements

Seeking a project manager to assist us with re-transmission agreements with various cable providers.

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    Greg |Vice-President & General Manager - Iowa

    Dear Mhegwood; My name is Greg Crosby and I am CEO of a firm called the NextGen Marketing Group. We...

    25 Minutes Later
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    Eva |TMT Specialist

    Hey mhegwood, Nice to hear from you. May I know for which market you have particular interest in, ...

    32 Minutes Later
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    Edward |VP Business Development

    Sorry, I'm not an expert on re-transmission...

    2.8 Hours Later
+7 Other Responses
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Re-insurance Industry

I am at the early stages of developing a business plan for a product and service that (i suspect but dont know) could be of interest in the fire re-insurance industry. Through software and hardware the intention is to develop a system by which fire sprinkler systems can be automatically monitored (where possible where actuated devices are used) and also to prompt and guide the correct inspections, tests and maintenance routines on all elements of an installed sprinkler system. The question i am trying to answer is, of what interest would that be to fire re-insurers, who today have effectively no visibility of whether fire safety checks are done in-line with legal/code requirements. Would the availability of independent evidence/proof be something that would be of any interest to reinsurers to the extent they would offer lower premiums? Thanks.

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    Byron |Fire Protection Specialist

    Very interesting. As a former sprinkler inspector I believe insurers are misled as to the reliabilit...

    1.5 Hours Later
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    Martin |Director

    Not my field I am afraid but good luck....

    1.6 Hours Later
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    Christopher |AVP

    yes, it would be of interest, especially if it monitors possible leakage. One of the biggest proble...

    1.7 Hours Later
+13 Other Responses
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