sharing the costs of professional training & courses
Specialist Regulatory Affairs
QIAGEN BUSINESS SERVICES
WrocławWrocław, Lower Silesia
- offer expired a month ago
- contract of employment
- specialist (Mid / Regular)
Prepare, compile and complete submissions to global regulatory entities for QIAGEN’s In vitro Diagnostic products
Ensuring compliance to the EU Medical Device Directive/in vitro Diagnostic Directive in Europe for QIAGEN products and knowledge of the EU Medical Device Regulation/in vitro Diagnostic Regulation
Compilation and review of Technical Files
Maintaining regulatory documentation for QIAGEN products as part of the Technical documentation.
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
Obtain and distribute updated information regarding international laws, guidelines, or standards
Developing regulatory infrastructure and documentation templates to support global submissions
Supporting internal stakeholders with product registrations and maintenance activities, customer enquiries and provision of regulated documents as required
S. in Biotechnology or related field with a minimum of 2 years of relevant work experience
Experience with CE Mark Technical File and Design Dossier submissions for Medical Devices, preferable
Knowledge of the European and other International regulations for IVDs preferable
Ability to comprehend principles of engineering, physiology and medical device use to achieve approval of global submissions
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.
Proficient use of Microsoft Office products suite and experience with SAP and Trackwise
Prior experience in handling global regulatory projects preferable
Proficiency in English and effective writing skills
Excellent communication skills
Ability to work in a fast-paced/entrepreneurial team environment
High degree of initiative with the ability to work independently with minimal supervision
Ability to prepare and present concise information to group
Experience working effectively in a cross-functional team setting
Capacity to plan and organize work while remaining flexible enough to handle multiple priorities
Experience working with global multi-lingual teams preferable
What we offer
Possibility to develop in an international company
Training and development programs
Private medical care
Group Life Insurance
Flexible benefits platform
Pension Scheme (PPE) after 12 months
Happy Monday :)
Casual dress code
Attractive location (Sky Tower)
no dress code
QIAGEN BUSINESS SERVICES
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.
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 in English as well as your earliest starting date and salary expectations.
We look forward to hearing from you!