Regulatory Affairs & Quality Lead - Region Europe
Job Location:Crawley, United Kingdom / Stockholm, Sweden
We don’t just build technology. We build hope for everyone dealing with Cancer.
The Regulatory Affairs & Quality (RAQ) Lead for Region Europe is responsible for overseeing and managing functions that support departmental initiatives and directives. This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for regulatory submissions and strategies.
What you’ll do at Elekta
Would you like to be part of our driven global team, where we aim to attract and invite the best competences to Elekta? We are offering you an exciting opportunity to join our Regulatory Affairs & Quality Team at either Crawley (UK) or Stockholm (Sweden) location, which is currently a team of eight team members spread globally over three regions.
In this exciting and diverse role, you will work closely with local organizations, ensuring compliance with legislation and representing Elekta in International regulatory bodies.
Responsibilities include:
* Support, create and maintain the Regional Submission Process(s) and Regulatory Roadmap for European region.
* Inform and support local organizations regarding changes in legislation, providing interpretation and strategic advice.
* Demonstrate leadership by delivering results, aligning priorities, and managing change.
* Be Elekta’s representative in the region in interactions with international bodies in the field of regulatory submissions with a potential to have an impact on Elekta’s businesses. This includes hosting external audits with Notified Bodies within the member states of the EU and regulatory authorities within Eastern European region where required.
* Support locally appointed regulatory and quality staff in respective areas in their interactions with national authorities and in preparations of submissions and compliance data.
* Supporting the onboarding of new regions including managing metrics.
What you bring
* More than 5+ years of experience working with regulatory affairs in European region. We are looking for stronger RA experience than QA expertise.
* Knowledge and proven track record in Regulatory Affairs for Medical Devices in European region.
* Knowledge of the European Directive for Medical Devices & experience of ISO 13485 would be preferred.
* Degree equivalent in an engineering related subject or a formal engineering apprenticeship with demonstrated experience in a similar role.
* A positive attitude towards change to promote the global goals of the business.
Why you will 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, 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 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
* Onsite subsidized restaurant, offering budget-friendly dining
* Love electric (Electric vehicle salary sacrifice scheme)
Sweden
* 30 paid vacation days/year, additional 4 Elekta days off /year (plus bank holidays)
* Attractive defined contribution pension scheme
* Private Medical Insurance
* Lunch Benefit
* Contribution to wellness activities
* Hybrid work option (you are required to work on location at least 3 days/week)
Hiring process
We are looking forward to hearing from you! Apply by submitting your application and resumé 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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