Regulatory Affairs and Quality Assurance Engineer
Regulatory Affairs and Quality Assurance Engineer
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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 dont 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 youll 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
Bachelors 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 solutionsoriented 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 dont meet every requirementyour unique skills and experiences might be exactly what were 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 resum in English via the Apply button. Please note that we do not accept applications by email.
Your Elekta contact
For questions please contact the responsible Global Talent Acquisition Partner Nidhi Sarkar .
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.
Employment Type
Full-Time
