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Location

Frankfurt am Main | Germany

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Job description

Innovative and responsible - your tasks are challenging.

• Maintain Regulatory Affairs product files to support compliance with regulatory requirements
• Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance. This includes reviewing labeling, promotional materials, training materials, changes to existing devices and documentation
• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners
• Prepare worldwide submissions for new products and their product changes as required
• Timely compile materials for license renewals, updates and registrations
• Maintain regulatory files/database and chronologies in good order
• Establish and maintain a system for tracking changes in documents submitted to agencies or partners
• Provide on-going support to project teams for regulatory issues and questions
• Review product changes for impact on regulatory filings worldwide
• Review labeling and labels for compliance with regulatory requirements
• Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws
• Provide the regulatory reviews of customer complaints
• Maintain current knowledge of EU, US and international regulation, guidance and standards applicable to company products
• Establish procedures and internal standards (e.g. SOPs, work instruction, forms and checklists)

Efficiency and perspective - your future is impressive.

• Talent management programmes
• Employee events
• Development of cross-divisional expertise

You have the best premises - show us them.

• Regulatory Affairs Certification desired
• Fluent in German and English language
• Analytical, accurate with an eye for detail
• Excellent organizational, communication (written and verbal) and negotiation skills
• Work independently
• Demonstrated ability to work successfully on cross-functional project teams
• Proficient in MS Word, Excel, PowerPoint, MS Project, and IT Systems
• International experience is a plus

Do you envision your future being involved in exciting projects of the aerospace industry? Then we are looking forward to your application - please send it online to Ms. Tamara Wurdak using the key number FE22-46420-F. Because what's valid for our customers has always been valid for you: follow your fascination!

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Job tags

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Salary