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Regulatory Affairs and Quality Assurance Engineer

Elekta

Crawley

Hybrid

GBP 40,000 - 80,000

Full time

Today
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Job summary

Join a forward-thinking company dedicated to improving lives through innovative medical technology. As a Regulatory Affairs & Quality Assurance Specialist, you will play a crucial role in ensuring compliance and regulatory clearances for life-saving products. This position offers a hybrid work environment, allowing flexibility while contributing to a mission that truly matters. Collaborate with diverse teams and engage with regulatory bodies to drive improvements in processes, all while being part of a supportive international team. This is your chance to make a meaningful impact in the healthcare sector and advance your career in a dynamic field.

Benefits

Up to 25 paid vacation days
Holiday Purchase Scheme
Private Medical Insurance
Attractive Employer Pension Contribution Package
Cycle to work scheme
Life Assurance

Qualifications

  • 5+ years of experience in regulatory affairs within the medical device industry.
  • Fluent in English; additional languages like Russian or Ukrainian are an advantage.

Responsibilities

  • Provide regulatory intelligence and support for Eastern European markets.
  • Act as a primary contact for all regulatory affairs matters in the region.

Skills

Regulatory Affairs
Quality Assurance
Interpersonal Skills
Problem Solving
Communication Skills
English Fluency
Knowledge of Medical Device Industry
Computer Proficiency

Education

Bachelor’s degree in Regulatory Affairs
Bachelor’s degree in Engineering
Bachelor’s degree in a related field

Job description

Are you a current Elekta employee?

Please click here to apply through our internal career site Find Jobs - Elekta .

Want to join a team with a mission to improve and save lives?

We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.

We currently have the following opportunity available - please contact us for more details!

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

Elekta is seeking a Regulatory Affairs & Quality Assurance Specialist who will 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 Ukrainian 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 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 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.

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