Regulatory Affairs Specialist - Software

Elekta AB; Crawley; Hybrid; GBP 35,000 - 65,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to join their mission of improving lives through innovative medical technology. In this role, you will be pivotal in ensuring regulatory compliance for software products, working closely with development teams and stakeholders. This position offers a hybrid work environment, allowing you to balance office presence with remote work. You will have the opportunity to contribute to meaningful projects that impact healthcare globally, all while being part of a dedicated team that values integrity and proactive problem-solving. If you are passionate about regulatory affairs and making a difference, this role is for you.

Benefits

Up to 25 paid vacation days

Holiday Purchase Scheme

Private Medical Insurance

Attractive Employer Pension Contribution Package

Cycle to work scheme

Life Assurance

Qualifications

• 3+ years of regulatory experience with class II and III medical devices.
• Excellent communication skills, especially with technical personnel.

Responsibilities

• Lead regulatory compliance planning and submission activities.
• Provide regulatory support to software development teams.

Skills

Regulatory Compliance

Communication Skills

Interpersonal Skills

Problem Solving

Project Planning

Education

Engineering or related field

Tools

File Management

Networking

Job description

Regulatory Affairs Specialist - Software page is loaded

Regulatory Affairs Specialist - Software

Apply locations Crawley time type Full time posted on Posted 6 Days Ago job requisition id R2025-0624

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.

Elekta is seeking a Regulatory Affairs Specialist – Software to support the RA – Software organization in achieving regulatory goals and objectives and proactively support the organisation in achieving and maintaining the necessary regulatory clearances needed globally.

What you’ll do at Elekta

This position offers Hybrid working with flexibility of working from office 3 days a week.

Responsibilities

1. Lead the regulatory compliance planning, reporting and submission activities.
2. Facilitate standards compliance verification activities and standards compliance for Elekta products and where applicable third-party manufacturers.
3. Provide regulatory intelligence to product teams and facilitate compliance and transition to new standards/regulations.
4. Provide regulatory support to software development teams by performing submission evaluations according to health authority change guidance, identifying appropriate standards, authoring submission documentation and communicating with internal and external stakeholders.
5. Conduct project planning and reporting meetings.
6. Assist in process improvements objectives, create and prioritize projects.
7. Assist with post-market reporting.
8. Commit to Quality - Adhere to and improve processes and work.
9. Drive change - Identify, plan, and implement changes.
10. Demonstrate integrity - Build positive relationships and deliver honest, dependable results.
11. Provide creative solutions – Offer proposals and ideas to solve problems.

What you bring

1. 3+ years of regulatory experience on class II and III Medical devices globally. SaMD experience preferred.
2. Professional and reliable.
3. Excellent interpersonal and communication skills, especially with technical personnel.
4. Proactive and solutions-oriented.
5. Computer literate with a basic knowledge of file management and networking.
6. Ability to interpret, adapt and provide guidance on product regulation.
7. Preferably knowledge and proven track record in RA.
8. Engineering or other related areas qualifications.
9. Methodical thinker with ability to interpret regulatory requirements and apply in meaningful business requirements.

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

1. Up to 25 paid vacation days (plus bank holidays)
2. Holiday Purchase Scheme
3. Private Medical Insurance
4. Attractive Employer Pension Contribution Package
5. Hybrid work option (you are required to work on location at least 3 days a week)
6. Cycle to work scheme
7. Life Assurance

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 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.