Senior Regulatory Affairs Engineer

Elekta; Crawley; Hybrid; GBP 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Senior Regulatory Affairs Engineer to join their dynamic team, dedicated to improving lives through innovative medical technology. This role involves ensuring compliance with global regulations, leading regulatory submissions, and collaborating with cross-functional teams to drive excellence in product safety. With a hybrid work model, you will contribute to a mission that impacts patients worldwide while enjoying a supportive work environment that fosters professional growth and development. If you are passionate about regulatory affairs and want to make a difference in the MedTech industry, this opportunity is perfect for you.

Benefits

Up to 25 paid vacation days

Holiday Purchase Scheme

Private Medical Insurance

Employer Pension Contribution Package

Cycle to work scheme

Life Assurance

Qualifications

• 5+ years in regulatory submissions within the medical device industry.
• Expertise in FDA, EU MDR, and ISO 13485 regulations.

Responsibilities

• Lead global regulatory submissions and approvals.
• Advise on regulatory requirements for product development.

Skills

Regulatory submissions

Project management

FDA regulations

EU MDR

ISO 13485

Communication skills

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Master’s degree in Life Sciences

Tools

Microsoft Office

ERP systems

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 don’t 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 you’ll do at Elekta

As a Senior Regulatory Affairs Engineer , you will play a pivotal role in supporting Elekta’s global regulatory strategy, ensuring compliance with international standards and regulations. This position offers the opportunity to work cross-functionally with product management, engineering, manufacturing, supply chain, and external authorities, driving regulatory excellence across the business.

You’ll 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 up-to-date 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.

• Bachelor’s or master’s 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 multi-cultural, cross-functional environment.

• Proficiency in Microsoft Office and ERP systems

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!

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 r e sumé 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 , [e-mail] .

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.