QIAGEN is one of the world’s leading biotechnology companies. With our sample to insight solutions that unlock valuable molecular information from biological samples, QIAGEN helps to improve healthcare and safeguard our societies, enables the development of new medicines and paves the way for scientific breakthroughs.
Join the revolution – and see how you can make a difference
Senior Specialist Regulatory Affairs
Job ID#: 6237
Location: Wroclaw (Breslau), Poland
Functional Area: Regulatory & Clinical Affairs
Employment Type: Regular Full-Time
Duration: unlimited
Position Description
- Provide Regulatory Affairs support for the International Registration Focus team;
- Liaise with internal QIAGEN stakeholders to ensure proposed product registrations are authorized;
- Support the International Registrar and the Global Data Center with regulatory international activities;
- Coordinate Post Market Surveillance Activities;
- Ensure data quality for the regulated products within the company databases.
Position Requirements
- Bachelor’s/master’s degree in life sciences or related field;
- Very good English skills;
- Experience in a similar role within a regulated industry (i.e. Pharmaceuticals, Medical Devices);
- Experience in invitro diagnostics would be of a great advantage;
- Working knowledge of the European and other International regulations;
- Proficient with Microsoft Office;
- Experience in working with SAP, (experience with Trackwise preferred).
Personal Requirements
- Good interpersonal and communication skills;
- Good analytical skills;
- Ability to handle multiple projects simultaneously.
We Offer
- Possibility to develop in an international company;
- Attractive office location in Sky Tower;
- Attractive benefits package;
- Language classes;
- Private medical care;
- Group Life Insurance;
- Friendly atmosphere;
- Happy Monday :)