Regulatory Affairs Specialist
Regulatory Affairs Specialist
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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.
What youll do at Elekta
At Elekta we dont just build technologywe build hope for everyone dealing with cancer. As a Regulatory Specialist you will play a critical role in ensuring our products meet regulatory requirements while enabling efficient order processing and delivery. Your work will directly impact how we serve hospitals clinicians and patients worldwide by maintaining compliance without compromising delivery timelines.
You will collaborate with stakeholders across Regulatory Affairs Product Management Order Handling Logistics and other key teams to manage regulatory block and release processes for products and spare parts. Your focus will be on process efficiency compliance and continuous improvement.
Responsibilities
Maintain and update the Regulatory Release Matrix to reflect new product registrations and releases.
Provide regulatory input for the catalogue and ensure catalogue accuracy against registrations; act as the main RA contact for the catalogue team.
Represent Regulatory Affairs in Order Process reviews and support unblocking activities.
Coordinate block and release activities to meet operational KPIs.
Drive process improvements and implement changes to enhance the block & release process.
Provide timely and accurate information to support order and spare part release decisions.
Report on process performance and update blocked/unblocked product status weekly.
Review RA Release Forecasts identify potential issues and propose corrective actions.
Support other tasks as assigned by your manager.
The right stuff
You are detail-oriented organized and proactive. You thrive in cross-functional settings and are passionate about compliance and operational excellence.
Strong communication and coordination skills across multiple teams.
Analytical mindset with a focus on process improvement.
Ability to work under pressure and meet tight deadlines.
A collaborative approach and a drive to find solutions.
What you bring
You bring expertise in regulatory operations and a passion for contributing to high-quality healthcare solutions.
Experience in regulatory affairs operations or order fulfillment processes (MedTech preferred).
Ability to interpret and apply regulatory requirements in operational processes.
Strong organizational and data management skills.
Experience working in matrixed or cross-functional teams.
Proficiency with ERP systems (e.g. M3) and regulatory tracking tools.
We encourage you to apply even if you dont meet every requirementyour unique skills and experiences might be exactly what were looking for!
What youll get
In this role you will work for a higher purpose hope for everyone dealing with cancer and for everyone regardless of where they are in the world to have access to the best cancer care. You will be part of a collaborative global team committed to delivering innovation and excellence.
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. In addition to this Elekta offers a range of benefits.
Hybrid work option (you are required to work from the Crawley HQ at least 3
days/week)
Up to 25 paid vacation days (plus bank holidays)
Holiday Purchase Scheme
Private Medical Insurance
Attractive Employer Pension Contribution Package
Cycle to work scheme
Life Assurance
Onsite subsidized restaurant offering budget-friendly dining
Love electric (Electric vehicle salary sacrifice scheme)
Hiring process
We look forward to hearing from you! Apply by submitting your application and rsum in English via the Apply button. Please note that we do not accept applications via e-mail.
Your Elekta contact
For questions please contact the Global Talent Acquisition Partner responsible Gustaf Ericson at . 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 6000 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 its personal and our global team of 4700 employees combines passion science and imagination to profoundly change cancer care. We dont just build technology we build hope.
Elekta is headquartered in Stockholm Sweden with a presence in more than 120 countries and listed on Nasdaq Stockholm. For more information visit or follow @Elekta on LinkedIn and Twitter.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
