Associate (m/f/d) Global Regulatory Affairs

FERCHAU GmbH; Deutschland; Vor Ort; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

A technology consultancy firm in Germany seeks an ambitious Associate in Global Regulatory Affairs. The role involves maintaining regulatory files, supporting marketed products, and preparing submissions for new products. Ideal candidates are fluent in German and English, possess strong analytical and organizational skills, and are proficient in MS Office. Join us to engage in exciting aerospace projects.

Leistungen

Talent management programmes

Employee events

Development of cross-divisional expertise

Qualifikationen

• Regulatory Affairs Certification desired.
• Fluent in German and English language.
• Ability to work independently and on cross-functional teams.
• Strong organizational, communication, and negotiation skills.

Aufgaben

• Maintain Regulatory Affairs product files for compliance.
• Provide regulatory support for marketed products.
• Prepare worldwide submissions for new products.
• Review labeling and compliance of advertising materials.

Kenntnisse

Regulatory Affairs Certification

Fluent in German and English

Analytical skills

Organizational skills

Communication skills

Negotiation skills

Independent working

Cross-functional teamwork

MS Office proficiency

International experience

Tools

MS Word

Excel

PowerPoint

MS Project

Jobbeschreibung

Connecting people and technologies. Finding the perfect match for our customers. Always finding the right experts for every challenge - that's our goal at FERCHAU, which is why we are looking for you: As someone ambitious who, like us, wants to take technology to the next level. We are involved in exciting projects for well-known customers across all technologies and sectors.
Associate (m/f/d) Global Regulatory Affairs

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 Mohr using the key number FE22-46420-F. Because what's valid for our customers has always been valid for you: follow your fascination!