Regulatory Affairs Specialist - Elekta
Elekta is proud to be the leading innovator of equipment and software used to improve, prolong and save the lives of people with cancer and brain disorders. Our advanced, effective solutions are created in collaboration with customers, and more than 6,000 hospitals worldwide rely on Elekta technology. The treatment solutions and oncology informatics portfolios are designed to enhance the delivery of radiation therapy, radiosurgery and brachytherapy, and to drive cost efficiency in clinical workflows. Elekta employs 3,600 people around the world. Headquartered in Stockholm, Sweden, Elekta is listed on NASDAQ Stockholm.
Elekta is looking for a Regulatory Affairs Specialist! The Company Elekta offers a global environment where entrepreneurial thinking is highly valued. You will be a part of a motivated and self-propelled team where you have the ability to influence the development of the company as well as your own career.
If you’re as passionate about humanity and innovation as Elekta is then we should meet.
Purpose of the role
Regulatory Affairs is the decision authority on regulatory, environmental and export control matters across the organization. The function proposes and implements company policy on regulatory issues such as: trade compliance, labeling review, product registrations, standardization, regulatory strategy, radiation safety etc.
Your key responsibilities will be the following:
Department & supervisor
The Regulatory Affairs Specialist reports to the Director Regulatory Affairs EMEA, Egbert Hovenkamp. You will work in the Dutch regulatory team with Regulatory Affairs Specialist, Engineers and Associate (4 FTE), all part of Elekta’s growing European team divided over 4 countries. You will work closely with these other teams.
The Regulatory Affairs Specialist supports the Elekta organization globally in the delivery of its products in a regulated environment. You will work closely with business areas including manufacturing and supply chain, research and development and engineering. You will liaison with regulatory authorities. This is a high impact role in a mid-size company with short communication lines that works in a fast paced dynamic environment and makes a meaningful contribution to Elekta’s business. The position is placed in Veenendaal, centrally located in The Netherlands and easily accessible to public transport and highway.
Elekta is proud to live by their values: