Oferta pracy

Specialist Regulatory Affairs



Powstańców Śląskich 95


At the heart of QIAGEN’s business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe. 
Our most valuable asset are our employees – more than 5000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.  
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day!

Specialist Regulatory Affairs
Numer ref.: 0090-203

Job ID: EMEA01268

Location: Wrocław    

Department: QA / QC / Regulatory Affairs                                

Employment Type: Regular Full-Time

Position Description

  • Prepare, compile and complete submissions to global regulatory entities for QIAGEN’s In vitro Diagnostic and Medical Device products.
  • Support worldwide Regulatory affairs team for product license renewals and updates.
  • Compilation and Life cycle management of the Technical Files for CE marked products.
  • Participation in internal and external audits from global agencies.
  • Maintain current knowledge base of existing and emerging global regulations to assist in future product development.
  • Supporting internal stakeholders with product registrations and maintenance activities, customer enquiries and provision of regulated documents.
  • Maintain applicable tracking databases.
  • May perform other duties as required or assigned.
  • Working as part of cross-functional, multi-cultural, international teams.

Position Requirements

  • A Bachelor’s degree in science-related field is preferred.
  • Some experience with the In vitro diagnostic industry or Medical Devices preferred.
  • Ability to comprehend principles of IVDs and medical devices’ use to achieve approval of global submissions.
  • Very good knowledge of English language.
  • Proficient use of Microsoft Office products suite (e.g. Excel, Word, Outlook and PowerPoint).

Personal Requirements

  • Strong organizational skills and meticulous attention to detail.
  • Demonstrates the ability to meet goals and targets whether they are individual goals, team deliverable, or the timely completion of duties and projects.
  • Excellent communication skills required for working in a cross-functional team setting.
  • Ability to work in a fast-paced/entrepreneurial team environment.
  • Ability to prepare and present concise information to group.
  • Capacity to plan and organize work while remaining flexible enough to handle multiple priorities.
  • Thrive in a fast-paced work environment, while possessing the ability to quickly change priorities and perform multiple tasks simultaneously.
  • Highly self-motivated.

What we offer

At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

We offer:

  • Possibility to develop in an international company
  • Training and development programs
  • Private medical care
  • Group Life Insurance
  • Multisport card
  • Flexible benefits platform
  • Language classes
  • Pension Scheme (PPE) after 12 months
  • Childcare subsidy
  • Happy Monday :)
  • Friendly atmosphere
  • Casual dress code
  • Attractive location (Sky Tower)

If this interdisciplinary challenge appeals to you, you can expect a highly motivated team that is looking forward to your support! Please apply online, quoting the reference number, with your complete application documents as well as your earliest starting date and salary expectations.

We look forward to hearing from you!


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