Student Worker Regulatory Affairs

Job Description

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com .

Responsibilities

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

Changing Fertility Care for Generations to Come

At CooperSurgical we are currently looking to recruit a Student assistance 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 in the office in Copenhagen and will report to the Regulatory Affairs Lead.

Position

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.

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, Sharepoint
• Open to other RA relevant tasks when asked
  
  
  

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
• Well organized with attention to detail and ability to carry out tasks independently
• 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