Senior Regulatory Affairs Engineer

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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.

Are you ready to play a vital role in ensuring patient safety and regulatory compliance in the medical technology space? At Elekta, we’re seeking a Senior Regulatory Affairs Engineer to join our Post Market Surveillance team, where you’ll help manage and resolve product complaints in line with global regulatory requirements.

Reporting to the Post Market Surveillance Manager, you’ll be responsible for overseeing complaint handling, ensuring timely reporting to authorities, and maintaining a robust escalation system. You’ll also collaborate across functions to support broader post-market activities as priorities evolve.

If you’re detail-oriented, proactive, and passionate about improving lives through precision healthcare, we’d love to hear from you.

What You’Ll Do At Elekta:

Your role will include but not limited to

• Support the Post Market Surveillance Manager developing, implementing and maintaining appropriate and consistent systems and procedures to meet the business objectives
• As a member of the complaint unit, ensure that all product safety cases are quickly identified, assessed for patient risk and escalated appropriately to ensure proper action and /or agency notification is taken
• Ensure the reporting of adverse events to the appropriate authorities are carried out within specified timeframes
• Liaise with external regulatory bodies and internal regulatory functions within Elekta on AE reportable complaints
• Provide awareness training, as required, to ensure that everyone in the Business is aware of the importance of Complaints and the need to deal with them in a timely manner
• Monitor that complaints are closed in accordance with the defined targets and make raising non-conformances where necessary
• Any other Post Market Surveillance activities as required to support the departmental goals

The Right Stuff:

• Excellent communication skills enabling independent and interactive working across the global Elekta organisation
• Ability to work within a multi-cultural environment and across time zones
• Willingness and ability to travel domestically and internationally

What You Bring:

*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!  

• Advanced qualification or experience in the medical device industry, preferably with global exposure
• Knowledge of Medical Device Regulatory Affairs, specifically Post Market Surveillance and Vigilance
• Experience with complaint handling requirements in the medical device industry
• Proven experience in regulatory affairs within the medical device industry, with a strong focus on post-market surveillance, vigilance, and product recalls.
• In-depth knowledge of EU and US medical device regulations, including hands-on experience with notified body audits.

What You’Ll 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. In addition to this, Elekta offers a range of benefits for UK:

• 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)

For Sweden:

• Hybrid work option (you are required to work on location at least 3 days/week) 
• 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 

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 Global Talent Acquisition Partner responsible, Sarah Elmasry, at Sarah.Elmasry@elekta.com. 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, colour, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic.