Senior Regulatory Affairs Engineer
Senior Regulatory Affairs 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.
Are you an experienced Regulatory Affairs professional with a passion for ensuring product safety and compliance in the MedTech industry Elekta is seeking a Senior Regulatory Affairs Engineer to join our dynamic team and help shape the future of precision radiation medicine.
What youll do at Elekta
As a Senior Regulatory Affairs Engineer you will play a pivotal role in supporting Elektas global regulatory strategy ensuring compliance with international standards and regulations. This position offers the opportunity to work crossfunctionally with product management engineering manufacturing supply chain and external authorities driving regulatory excellence across the business.
Youll contribute directly to securing regulatory approvals and shaping regulatory strategies with a focus on the US FDA Health Canada EU MDR China Japan and other global markets.
This position offers Hybrid working with flexibility of working from office 3 days a week. We are open to considering applications from Crawley UK.
Responsibilities
Lead and support global regulatory submissions and approvals for target markets.
Advise on regulatory requirements and integrate them into product and process development.
Serve as a key liaison with internal departments and external regulatory authorities.
Develop and improve regulatory processes ensuring ongoing compliance and efficiency.
Mentor junior team members and contribute to team knowledge and capability development.
Maintain uptodate expertise on global medical device regulations and industry trends.
Provide expert support in audits and inspections both internal and external.
What you bring
5 years of experience in regulatory submissions and project management in the medical device industry.
Bachelors or masters degree in engineering Life Sciences or a related technical field.
Strong working knowledge of FDA EU MDR ISO 13485 and other global regulations.
Proven ability to interpret complex regulations and convert them into actionable business practices.
Excellent written and verbal communication skills in English.
Strong initiative integrity and a collaborative mindset.
Experience working in a multicultural crossfunctional environment.
Proficiency in Microsoft Office and ERP systems
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 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
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.
Required Experience:
Senior IC
Employment Type
Full-Time
