Regulatory Affairs Engineer - PMS Program Management

Elekta; Crawley; Hybrid; GBP 40,000 - 80,000; Full time

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.

Elekta is looking for a highly skilled Regulatory Affairs Engineer – Post Market Surveillance Program Management to join our team and contribute to the ongoing success of our regulatory operations.

The Regulatory Affairs Engineer – Post Market Surveillance (PMS) Program Management will play a critical role in maintaining compliance with regulations and company requirements. This position will involve managing and coordinating assigned PMS Product Report activities, ensuring timely development of reports, supporting audits, and contributing expertise to regulatory processes.

What you’ll do at Elekta

Responsibilities

1. Participate in Post Market Surveillance (PMS) Product Report activities with cross-functional teams to ensure compliance and accuracy.
2. Manage the development of Product PMS Plans and Reports (e.g., Post Market Surveillance Report, Periodic Safety Update Report) in accordance with regulatory schedules.
3. Serve as a subject matter expert (SME) in PMS Product Report processes, providing guidance and expertise to stakeholders.
4. Support internal and external audits by providing necessary information, documentation and insights into PMS activities.
5. Maintain procedures, work instructions, and training materials for PMS Product Report program management.
6. Coordinate with the PMS Department and subject matter experts (SMEs) to align objectives and timelines.
7. Assist in the development of data collection systems to facilitate PMS Product reporting.
8. Conduct trend and competitor analysis to support PMS initiatives.
9. Ensure proper records management for PMS activities and documentation.
10. Respond to external requests for information regarding PMS activities and regulatory compliance.
11. Continuously seek and implement process improvements to enhance PMS program efficiency.
12. Escalate risks and issues to management and represent PMS in internal and external discussions.

What you bring

1. Experience in medical devices and/or Elekta products preferred.
2. Experience in regulatory affairs within the medical devices industry preferred.
3. Strong knowledge of Medical Device Regulatory Affairs and compliance requirements.
4. Proven ability to work independently and collaboratively in a regulated environment.
5. Experience in project management within regulatory affairs is a plus.
6. Ability to influence stakeholders and drive results through structured problem-solving.
7. Excellent written and verbal communication skills in English.
8. High level of personal integrity and ethics in handling regulatory matters.
9. Strong proficiency in Microsoft Office and other relevant software applications.
10. Comfortable working in a multi-cultural environment with the ability to adapt to different regulatory approaches.
11. Must be able to travel (around 10%) as required for audits and regulatory meetings.

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.