About Elekta

The purpose of all the work we do at Elekta is to help clinicians improve patients’ lives. 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. Our 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 4,200 people around the world. Headquartered in Stockholm, Sweden, Elekta is listed on NASDAQ Stockholm. http://www.elekta.com

 

TILLSATT - Senior Regulatory Affairs Engineer, Elekta Solutions

Exciting opportunity to be part of Elekta, an innovative Swedish global leader within medical technology

Legal entity: Elekta Solutions AB
Reports to: VP Regulatory Affairs & Quality
Location: Elekta HQ, Stockholm preferably (other locations could be considered)

The Senior Regulatory Affairs (RA) Engineer is responsible for supporting functions related to gaining market access for our regulated products and submissions, communications with business lines and regional teams, collection of materials, analyzing and preparing responses on governing agency actions.

This role will also focus on regulatory intelligence including maintenance of related processes, gathering input and communication with business lines and regional teams. To be a source of knowledge, expertise, information, guidance and coaching on all aspects of Quality System Management and regulatory compliance. To support the quality agreements between respective Business line and Elekta Solutions are fulfilled.

Opportunitites with the role
- Work for Elekta a Swedish leading global medical technology company with an innovative and attractive company culture
- Take on an important cross functional, dynamic, key role with the opportunity to be an important part of the ongoing company development
- Be part of innovative projects that improve the treatment of life threatening diseases globally
- Be part of a professional and multi-cultural RA & Quality team with great spirit and collaboration culture
- There are extensive opportunitites for personal and professional career development in Elekta globally

Relevant knowledge, skills and competencies
- Regulatory Affairs management experience in the medical device manufacturing industry.
- Professional integrity with an ability to interpret, adapt & provide guidance on product regulation and translate into meaningful - business requirements.
- Objective driven and customer focused, with an ability to influence people. Capable of producing results working unsupervised under own initiative.
- A structured approach to problem solving.
- An effective team player who can mentor and lead problem solving to provide solutions to the business.
- Confident and open personality who can communicate effectively, both written and orally with people at all levels.
- A positive attitude towards change to promote the global goals of the business.
- Expert knowledge and proven track record in Regulatory Affairs for Medical Devices.
- Proficient in Microsoft Office applications
- Degree equivalent in an engineering related subject or a formal engineering apprenticeship with demonstrated experience in a similar role.
- Able to work within a multi-cultural environment.

Contact
For more information, inquiries, interest and application regarding the Senior Regulatory Affairs Engineer at Elekta Solutions, please contact Magnus Klingberg Senior Recruitment Consultant at PeakSearch. Apply for the position at http://www.peaksearch.se

Contact information:
Magnus Klingberg: magnus.klingberg@peaksearch.se , 070 678 09 92, 08 545 00 100.
http://www.peaksearch.se