Job Description

Stockholm, Sweden

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

Elekta is seeking a

Regulatory Affairs & Quality Assurance Specialist

whowill play a key role in acquiring and maintaining necessary regulatory clearances, liaising with regulatory bodies, and implementing regulatory strategies to support business objectives.

What you'll do at Elekta

This position offers

Hybrid working

with flexibility of

working from office 3 days a week

.


We are open to consider applications from

Crawley, UK

or

Stockholm, Sweden.

Responsibilities

Provide regulatory intelligence and support for Eastern European markets. Act as a primary contact for all regulatory affairs (RA) matters in the region. Support regional commercial teams with regulatory guidance. Collaborate with the Market Access Submission group for efficient submission processes. Recommend and implement improvements in regulatory processes. Work with Business Line RA to address regulatory challenges. Liaise with external regulatory bodies and internal stakeholders. Act as a point of contact for Quality Assurance (QA) processes in the region. Ensure adherence to and improvement of quality processes. Identify, plan, and implement necessary changes in regulatory operations.

What you bring

Bachelor's degree in Regulatory Affairs, Engineering, or a related field. Minimum of 5 years of experience in regulatory affairs within the medical device industry. Fluent in English; additional languages like Russian or Ukranian are an advantage. Professional, reliable, and highly motivated. Strong interpersonal and communication skills, particularly with technical teams. Proactive problem solver with a solutions-oriented approach. Ability to work independently and take initiative. Proficient in computer use with knowledge of file management and networking. Ability to

travel up to 15 %

of the time.

We encourage you to apply even if you don't meet every requirement--your unique skills and experiences might be exactly what we're looking for!

Why should you join Elekta?

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, to have access to the best cancer care. You will be part of our international innovative team and given the opportunity to learn and develop.


Overview of some of our benefits for United Kingdom & Sweden are as below.

United Kingdom

Up to 25 paid vacation days (plus bank holidays)*
Holiday Purchase Scheme*
Private Medical Insurance*
Attractive Employer Pension Contribution Package*
Hybrid work option (you are required to work on location at least 3 days a week)*
Cycle to work scheme*
Life Assurance*

Sweden

30 vacation days/year, plus an additional 4 Elekta days off/year (plus bank holidays).*
Attractive defined contribution pension scheme.*
Hybrid work option (you are required to work on location at least 3 days a week)*
Private Medical Insurance.*
Lunch Benefit.*
Contribution to wellness activities.*

Hiring process

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

Your Elekta contact

For questions, please contact the responsible Global Talent Acquisition Partner, Nidhi Sarkar, nidhi.sarkar@elekta.com .

We are an equal opportunity employer

We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, genetic information, national origin, disability, veteran status, or any other status protected by law in the locations where Elekta operates.

About Elekta

Here at Elekta, you will make a difference. We are a MedTech company that provides software and hardware to hospitals and clinics all over the world.


We have a responsibility toward our partners and customers to deliver solutions in a secure and sustainable way. Both when it comes to financial and environmental matters, but also for our employees to feel that they bring value, wherever in the organization they may work.