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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

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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:

  • Ensure regulatory compliance of medical devices with regulations on country level and in country of delivery and executes all required regulatory activities.
  • 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.
  • Preparation and maintain of regulatory documents (declarations, summary reports 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 support to suppliers and purchasing, marketing and engineering departments in regards to compliance with regulatory requirements, review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies
  • Coordinating Free Sale Certificate issuance upon customers request, prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Registration of Economic Operators in EUDAMED (Local Actor Administration-LAA)
  • SK-EN translation of required documentation.

Required knowledge, skills and experience:

  • Academic degree in life sciences, chemistry, technical/engineering education
  • 2 years experience in Regulatory Affairs, clinical or related field
  • Expertise in laboratory analysis, manufacturing procedures and clinical testing is advantage
  • Advanced computer skills (MS Office)
  • Advanced Slovak and English language skills is a must (verbal and written)
  • High attention to details
  • Strong analytical and organizational skills
  • Precise planning and execution to achieve accurate and timely results
  • 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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