Senior Specialist Regulatory Affairs

Location: Wroclaw (Breslau), Poland

Functional Area: Software Development
Employment Type: Regular Full-Time
Duration: unlimited

• 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.

• 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.

• Good interpersonal and communication skills.
• Great team player.
• Willing to travel when required by the business.