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

Are you an experienced Regulatory Affairs professional with a passion for ensuring product safety and compliance in the MedTech industry? Elekta is seeking a Senior Regulatory Affairs Engineer to join our dynamic team and help shape the future of precision radiation medicine.

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

As a Senior Regulatory Affairs Engineer, you will play a pivotal role in supporting Elekta’s global regulatory strategy, ensuring compliance with international standards and regulations. This position offers the opportunity to work cross-functionally with product management, engineering, manufacturing, supply chain, and external authorities, driving regulatory excellence across the business.
You’ll contribute directly to securing regulatory approvals and shaping regulatory strategies, with a focus on the US FDA, Health Canada, EU MDR, China, Japan, and other global markets.
This position offers Hybrid working with flexibility of working from office 3 days a week. We are open to considering applications from Crawley, UK.

RESPONSIBILITIES

• Lead and support global regulatory submissions and approvals for target markets.
• Advise on regulatory requirements and integrate them into product and process development.
• Serve as a key liaison with internal departments and external regulatory authorities.
• Develop and improve regulatory processes, ensuring ongoing compliance and efficiency.
• Mentor junior team members and contribute to team knowledge and capability development.
• Maintain up-to-date expertise on global medical device regulations and industry trends.
• Provide expert support in audits and inspections, both internal and external.