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#: 9479
Location: Wroclaw (Breslau), Poland
Functional Area: Software Development
Employment Type: Regular Full-Time
Duration: unlimited
Position Description
- Ensure compliance to the EU Medical Device Directive / In vitro Diagnostic Directive and IVDR in the Europe for QIAGEN Products.
- Responsible for change control triage and assessing the RA impact of changes worldwide.
- Participate in project teams to provide regulatory input into cross-departmental change control projects.
- Prepare documentation in order to support Global regulatory submissions.
- Compile and review Technical Files.
Position Requirements
- Minimum scientific degree (or equivalent) in life sciences.
- Very good knowledge of English language.
- Experience in the medical device industry, preferably in vitro diagnostics in a similar role.
- Working knowledge of the MDD and IVDD, applicable ISO standards and US medical device/IVD regulation.
- Good IT skills: Microsoft and Adobe.
- Ability to handle multiple projects simultaneously.
Personal Requirements
- Good interpersonal and communication skills.
- Great team player.
- Willing to travel when required by the business.
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 :)
