Regulatory Affairs Master Data Specialist
We are looking for a Regulatory Affairs Master Data Specialist for our Regulatory Affairs department in Denmark. It is a newly created position, and you will be a part of a team of 30 dedicated colleagues working with regulatory activities in a global environment, which requires excellent communication skills and a flair for collaboration at all levels. The Regulatory Affairs Master Data Specialist is a key member of the Regulatory Affairs (RA) function and responsible for managing regulatory affairs system needs and for the delivery of regulatory system projects. Your main responsibility will be the implementation of new systems and tools and the maintenance of these in Regulatory Affairs.
Your main responsibilities as a Regulatory Affairs Master Data Specialist will be:
- Liaise between IT systems and Regulatory Affairs, translating business and regulatory requirements into user-friendly solutions.
- Represent Regulatory Affairs in local and global project teams, ensuring compliance with regulatory requirements and guidelines for regulatory operations
- Be the generalist, who drives and implements new regulatory systems/tools and new processes from analysis via development, test and implementation of the systems to the users of the system, such as:
- implementing electronic data management systems and submission/document management systems including a filing system for archiving of regulatory data and documentation
- implementing global dashboards and developing local dashboards in order to provide project visibility
- Handle the day-to-day maintenance of the systems, continuously looking for process improvement of systems and their use, e.g.,
- implementing new versions or developing new types of reports
- organizing and uploading data to the systems in collaboration with the regulatory team members
- training of regulatory team members in using the systems and tools on a daily basis as needed
- create overview of how regulatory systems are working, and how they might be connected
- Participate in relevant external network groups
As a Regulatory Affairs Master Data Specialist, you are expected to have the following qualifications:
- Bachelor’s or Master’s degree or equivalent combination of education and related work experience
- Experience in development and maintenance of master data
- Preferably, previous experience as a project manager implementing new systems/tools
- Experience of process improvements and business change management is considered an advantage
- Previous experience from a similar position in the medical device or pharmaceutical industry is preferred, but this is not a requirement
- Strong quality mindset
- Fluent in English and Danish, both oral and written
- Superuser in Excel and experience of other relevant systems
You have an eye for detail while still the ability to juggle multiple tasks and projects across the organization in a thorough and systematic way. Your systematic approach and orientation towards details is characteristic of everything you do. You work independently within your own areas of responsibility. Proven ability to exercise sound judgement in independent decision making. Importantly, we expect you to be an excellent team player with a positive and committed approach to your tasks. You have excellent communication skills at all levels. Finally, you wish to work in a global, yet local environment.
We are looking for a positive and vigorous person who is ready for new challenges and for building up a new position at Cook Medical in Denmark.
Cook Medical has a healthy company culture with a strong common set of values. Responsible, competent and professional staff is our most important resource.
We have a flat organizational structure and focus on open dialogue. Qualities such as determination, loyalty and humour are highly appreciated.
The staff of Cook Medical helps to uphold the company’s philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide - we make a difference every day.
Cook Medical offers a well-organized internal training course which is taken by all new staff to enable them to quickly gain thorough knowledge of the company.
In addition to a salary package with pension, we offer flex time, a bonus system, health insurance, as well as free use of the company’s own gym.
For further information about the job, please feel free to contact Marianne Høy, Manager, Regulatory Affairs by phone: +45 56 86 87 87 or Henriette Stordal Christiansen, Director of Regulatory Affairs by phone: +45 56 86 87 56.
Deadline for applications is August 6, 2018