Regulatory Affairs Student
2 days ago
About CooperSurgical:
CooperSurgical Fertility Solutions is the global leader in IVF and reproductive genetics, providing innovative products, services, and training for every step in the ART journey. We are a truly international organization with a very dynamic working environment and excellent opportunities for growth and development
Job Summary:
At CooperSurgical we are currently looking to recruit a Student worker for regulatory affairs. You will be part of a dynamic Clinical and Regulatory Affairs team. The candidate can be placed in greater Copenhagen, Denmark. This position will be in the office in Copenhagen and will report to the Regulatory Affairs Lead.
In this student assistance role in Regulatory Affairs, you will be responsible for supporting the RA team on the Global MDR Project. Your daily tasks will evolve around compiling, administrating and collecting documents from global affiliates, assisting in uploading technical files, and ensuing data management and compliance.
You will be working in an international environment in a department that interacts with various departments. Furthermore, you will play a vital role in maintaining and uploading documentation, related to the maintenance of the CE marking of the products.
In the role of a student worker, you will play an important role from where you can excel and advance.
In this student assistance role in Regulatory Affairs, you will be responsible for supporting the RA team on the Global MDR Project. Your daily tasks will evolve around compiling, administrating and collecting documents from global affiliates, assisting in uploading technical files and ensuing data management and compliance.
Your qualifications:
- Current university or master degree student preferably within LifeScience
- Be able to work 15-20 hours per week
- Have skills working with Microsoft Office (particularly Excel, PowerPoint and Outlook)
- Experienced user with software in general and a quick learner
- Good communication skills both verbal and in writing
- Be a good team player, flexible and a strong sense of professional duty, enthusiastic, curious, minded doing routine assignments, focused, analytical, structured
Fluent English (spoken and written) is mandatory
Why join CooperSurgical?
We can offer a challenging position within a dynamic, globally leading, high growth company. You will work together with competent and international colleagues in a positive environment, that welcomes people of all views and backgrounds and provides countless ways to advance and thrive.
Interested?
To ensure we continue improving the quality of treatments for women and families, we offer roles that challenge individuals and helping them grow. To make this happen we provide high-quality training and through collaborative project work and peer support, we believe our work environment helps to nurture talent enabling everyone to excel.
Your key responsibilities:
- Supporting and collecting documentation from affiliates globally
- Compiling Technical Documentation for ROW registrations
- Upload and maintenance of documents in Master Control
- Updating and maintaining regulatory technical documentation
- Archiving activities
- Updating and maintaining sheets and documents in SmartSheet and Sharepoint
- Open to other RA relevant tasks when asked
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