RA Coordinator, CooperSurgical / 1647
Positive & Proactive
• Worldwide leading company within its field of activities
• Scope and manage RA activities with internal & external stakeholders
• Good overview, sense of detail and like to work in a team
CooperSurgical Fertility and Genomic Solutions is the global leader in IVF and reproductive genetics, providing innovative products and services for every step in the ART journey. Regulatory Affairs is responsible for global regulatory activities and approval of high-risk IVF media.
You will be part of scoping and managing RA activities with internal & external stakeholders to meet deadlines. You will work cross the organisation and with other members of the RA Team. The RA Coordinator shall have the qualifications which make the candidate able to solve the tasks dedicated in accordance with the department’s budgets, politics, procedures and instructions.
Among others your task will be:
• Labeling worldwide in accordance with relevant legislation
o Writing and maintaining labels and IFUs in D4
o Approval of marketing material
o Handling of country specific labeling
• Implementing and maintaining new label process
• Handling of Annual Updates (Canada, US (FURLS), ARTG etc.)
• Updates of various databases (GUDID, EUDAMED, ARTG, WAND etc.)
• Maintain RA QP/QI’s in the QA system in corporation with colleagues in RA
• Product registrations in countries where application is based on the EU Design Examination
• Implementations of new obtained registrations
• Maintenance of various registration lists
• Structure/maintenance of department documentation folder
You will be offered a challenging job in an international company. You will be part of the Global RA Team which consist of 10 dedicated people. And you will report to the Senior Director Regulatory Affairs.
You have 3-4 years of experience within RA or QA and have a Project Management mindset. You have a relevant Bachelor e.g. Nurse or Pharmaconomist, and you like to work with standards and communicate with authorities. Your experiences come from the MedTech industry and you are IT savvy.
You are a self-starter and confident to communicate at all levels. You are flexible, able to juggle a number of projects simultaneously, with a good overview and at the same time you have an eye for detail. You are quality oriented and always in search of efficiency gains, where you coordinate and complete full workflow from start to end of RA projects. You have the ability to work independently and as part of a project team and are keen on working in a multicultural environment.
As a person you are ambitious, dedicated and have a passion for RA. You have an analytical mindset, are systematic, structured, and good at solving problems. You work result oriented, but at the same time positive and with a good sense of humor.
Although we seek an experienced person, we also encourage less experienced, talented and visionary people, where this could be your next career step to apply.
Fluency in English with good verbal and written language skills is a given.
CooperSurgical Fertility and Genomic Solutions is the global leader in IVF and reproductive genetics, providing innovative products and services for every step in the ART journey. People at the HQ in Denmark work with colleagues worldwide to increase the quality of partnerships with clinics across the globe and the quality of treatments for women and families.
CooperSurgical Medical Devices are trusted and innovative brands that help improve the health of women, babies and families worldwide. CooperSurgical company are owned by The Cooper Companies.
CooperSurgical Fertility and Genomic Solutions provides a trusted system of consumables, equipment, technologies and genetic testing for the complete ART process. They drive and evolve innovation in line with customer needs; offering tailored product solutions, delivering world-class evidence-based training, and organizing expert-led workshops.
As trusted brands, their products and services continue to meet stringent standards, and their high-quality manufacturing facilities and genetic testing laboratories have been specifically designed for the development of ART products and services.
Working with experts and key opinion leaders in the field, they have dedicated research and development teams. CooperSurgical are continually developing innovative products, revolutionary technology and services using the latest clinical research, to help improve clinical workflows, processes, productivity and outcomes.
HQ is placed in Måløv, Denmark.
Best Talent is responsible for the recruitment for this position at CooperSurgical and review your application on a confidential basis. Forward your application including your CV attention ”1647/RA” by way of e-mail to email@example.com. You can read more about Best Talent at www.besttalent.dk.