WE DON’T JUST BUILD TECHNOLOGY. WE BUILD HOPE FOR EVERYONE DEALING WITH CANCER.

Elekta is seeking a Regulatory Affairs Specialist – Software to support the RA – Software organization in achieving regulatory goals and objectives and proactively support the organisation in achieving and maintaining the necessary regulatory clearances needed globally.

HIRING PROCESS

We are looking forward to hearing from you! Apply by submitting your application and resumé in English, Please note that we do not accept applications by e-mail.

WHAT YOU’LL DO AT ELEKTA

This position offers Hybrid working with flexibility of working from office 3 days a week.

RESPONSIBILITIES

• To lead the regulatory compliance planning, reporting and submission activities.
• To facilitate standards compliance verification activities and standards compliance for Elekta products and where applicable third-party manufacturers.
• To provide regulatory intelligence to product teams and facilitate compliance and transition to new standards/ regulations.
• Provide the regulatory support to software development teams by performing submission evaluations according to health authority change guidance, identifying appropriate standards, authoring submission documentation and communication with internal and external stakeholders.
• Conduct project planning and reporting meeting.
• Assist in process improvements objectives Create and prioritize projects.
• Assist with post-market reporting
• Commits to Quality - Adheres to and improves processes and work.
• Drives change - Identifies, plans, and implements changes.
• Demonstrates integrity - Positive relationships and honest dependable results.
• Provides creative solutions – Offers proposals and ideas to solve problems.