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Track Your QSR Shipment

Online tracking available for Twinsburg-based accounts only. For other QSR locations, select below for more information.

Your QSR Account Number can be found on your invoices and packing slips in the format of "1234-56"

For order tracking in Jasper, GA, contact your QSR customer service representative:

Vikki Stanger
[email protected]
706-692-8626

For order tracking in Jasper, GA, contact your QSR customer service representative:

Vikki Stanger
[email protected]
706-692-8626

We are looking for a candidate with high attention details and strong analytical skills, who will ensure regulatory compliance of medical devices with regulations on country level and in country of delivery and executes all required regulatory activities.

Main responsibilities:

  • Responsibility for coordination and preparation of regulatory product notifications and registrations in given timelines.
  • Contact with State Institute for Drug Control and Slovak Chamber of Commerce and Industry to register new medical products or update existing registrations.
  • Preparation and update of technical files and internal documents.
  • SK-EN translation of required documentation.
  • Preparation and maintain of regulatory documents (declarations, summary reports, clinical evaluation, summary of relevant web search etc.) required for marketing approvals in different countries.
  • Legalization of documentation and certificates via notary offices, embassies and Ministry of Foreign Affairs as necessary to obtain and sustain product approval.
  • Supporting Registration of customers in international markets.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Decomposition of products in connection with exports and ensuring Certificate of Country of Origin.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Regulatory support to marketing and engineering departments

 

Required knowledge, skills and experience:

  • Academic degree in life sciences, chemistry, technical/engineering education
  • Regulatory Affairs experience, clinical or related field 1-2 years
  • Advanced computer skills (MS Office)
  • Advanced Slovak and English language skills (verbal and written)
  • High attention to details
  • Strong analytical and organizational skills
  • Ability to understand cross-enterprise data flow and systems
  • Precise planning and execution to achieve accurate and timely results
  • Strong interpersonal skills
  • Strong writing skills
  • Team player

Apply

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Attachments must be .doc, .docx, or .pdf files and must not exceed 5mb.

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