Lead Regulatory Affairs Engineer

Lead Regulatory Affairs (Ra) Engineer

We don't just build technology. We build hope for everyone dealing with cancer.

What you'll do at Elekta:

As a Lead Regulatory Affairs (RA) Engineer, you will coordinate and manage the delivery of regulatory expertise across projects, ensuring alignment with Elekta's release and domain strategies. You will play a vital role in supporting regulatory submissions and maintaining compliance while also working ahead of project teams to ensure smooth execution and adherence to regulations. Your scope will include leading RA planning and backlog management, supporting PI planning, and acting as a deputy for the Director of RA when needed.

Key responsibilities include:

• Act as functional interface to the Project Management Office for regulatory needs
• Manage the RA task backlog and ensure resource planning in coordination with the Director of RA
• Provide regulatory expertise across domain and release projects
• Drive execution of RA management decisions
• Proactively identify and lead continuous improvement opportunities
• Support the development of departmental strategies and training
• Represent RA in roadmap discussions and cross-functional planning
• Participate in PI planning and raise regulatory actions for planning cycles
• Ensure adherence to global regulatory and safety requirements
• Support worldwide regulatory submissions including FDA, Health Canada, Japan, and China
• Deputize for RA Director and substitute for RA engineers when needed

The right stuff:

• Strong leadership and conflict resolution abilities
• Ability to influence and build strong cross-functional relationships
• Effective communication skills at all organizational levels
• Collaborative mindset with the ability to mentor and drive problem-solving
• Structured, detail-oriented and able to work independently
• Positive attitude toward change and continuous improvement

What you bring:

• At least 7 years of experience in Regulatory Affairs within the medical device industry
• Proven project or program management experience, preferably in Agile environments
• Experience with radiotherapy or radiosurgery is a plus
• Familiarity with international regulatory standards and submissions
• BSc or MSc in Engineering or equivalent
• Experience with quality assurance, compliance, and audits
• Proficient in Microsoft Office and common IT tools
• Excellent English language skills (written and verbal)
• Experience working in a multicultural environment

What you'll get:

In this role, you will work for a higher purpose: hope for everyone dealing with cancer, and for everyone - regardless of where in the world they live - to have access to the best cancer care. In addition to this, Elekta offers a range of benefits.

Hiring process:

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

Your Elekta contact:

For questions, please contact the Global Talent Acquisition Partner responsible, Gustaf Ericson, at gustaf.ericson@elekta.com. We do not accept applications through e-mail.

We are an equal opportunity employer:

We are an equal opportunity employer. We evaluate qualified applicants without regard to age, race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic.

About Elekta:

As a leader in precision radiation therapy, Elekta is committed to ensuring every patient has access to the best cancer care possible. Elekta is a proud innovator and supplier of equipment and software used to improve, prolong, and save the lives of people with cancer and brain disorders.

More than 6,000 hospitals worldwide rely on Elekta technology. We openly collaborate with customers to advance sustainable, outcome-driven, and cost-efficient solutions to meet evolving patient needs, improve lives and bring hope to everyone dealing with cancer. To us, it's personal, and our global team of 4,700 employees combine passion, science, and imagination to profoundly change cancer care. We don't just build technology, we build hope.

Elekta is headquartered in Stockholm, Sweden, with presence in more than 120 countries and listed on Nasdaq Stockholm. For more information, visit elekta.com or follow @Elekta on Twitter and on LinkedIn.