Ian Herrman

Experience

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  Iowa State University

  Aug 2011 - Aug 2013

  Student Assistant in the Value-added Ag. Program

  Data Analysis (looking at different agricultural product information like bushels per year and export/import values), website maintenance and updates, budgeting, student outreach (at events like the Future Farmers of America convention), Fielding users questions about different products and finding the information for them, or pointing them in the right direction, Video creation.

• 

  Cook Medical

  Jul 2014 - now

  Support Cook Medical by performing the following regulatory functions:Author or support regulatory submissions to the FDA (primarily 510(k)s)Author Clinical Evaluation Reports (CERs)Assess changes for potential regulatory actions and prepare global assessmentReview marketing materials for regulatory complianceProvide regulatory strategy for market expansionReview Design History File documents for regulatory complianceServe as the primary contact for non-regulatory functions for regulatory questions related to product line (Reproductive Health Product)Act as Liaison between international regulatory specialists and other functionsDevelop and update regulatory quality system instructions and procedures as necessary Show less Regulatory Specialists help develop regulatory strategies, obtain and maintain approval, and serve as a communication liaison between the Cook manufacturer and the Cook International Local Office / Cook Distributor. • Serves as a liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor • Communicates country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assists with the regulatory strategies • Plans and prepares regulatory submissions for new products, product changes, and re-registrations as required for the specificcountries/regions Show less

  • Regulatory Affairs Specialist – Reproductive Health Product Specialist, US Team

    Jul 2018 - now

  • Regulatory Affairs Specialist - China Team

    Jul 2014 - Jul 2018