Regulatory Affairs Specialist

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We don’t just build technology. We build hope for everyone dealing with Cancer.

Elekta is shaping the standard of care, together with healthcare providers, by developing precision radiation medicine that brings advanced radiotherapy into routine clinical practice. Our solutions support consistent, efficient and personalized care, addressing evolving patient needs. Through adaptive radiotherapy, precision treatment delivery and integrated workflows, Elekta supports care teams across a range of clinical settings. Each year more than 2 million patients are treated using Elekta solutions across over 130 countries. Elekta is headquartered in Stockholm, Sweden, with over 4,000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information, visit elekta.com .

We don’t just build technology. We build hope for everyone dealing with Cancer.

Elekta is shaping the standard of care, together with healthcare providers, by developing precision radiation medicine that brings advanced radiotherapy into routine clinical practice. Our solutions support consistent, efficient and personalized care, addressing evolving patient needs. Through adaptive radiotherapy, precision treatment delivery and integrated workflows, Elekta supports care teams across a range of clinical settings. Each year more than 2 million patients are treated using Elekta solutions across over 130 countries. Elekta is headquartered in Stockholm, Sweden, with over 4,000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information, visit elekta.com.

Regulatory Affairs Specialist

What You’ll Do At Elekta

This role is based in Warsaw and follows a hybrid working model, with four days per week in the office and one day working remotely. As a Regulatory Affairs Specialist, you will play a key role in ensuring the regulatory release and compliance of assigned Elekta products and spare parts. Working closely with cross-functional stakeholders across Regulatory Affairs, Product Management, Order Handling, Logistics, Technical Publications, Localization, and other business functions, you will help ensure products can be released predictably and in compliance with applicable regulatory requirements. You will also contribute to the continuous improvement of regulatory processes and tools that support Elekta’s global operations.

Responsibilities

• •Coordinate regulatory block and release activities for assigned Elekta products and spare parts.
• •Maintain and update the regulatory blocked and unblocked product status within ERP systems.
• •Review release forecasts, identify potential issues, and support corrective actions to ensure timely product availability.
• •Provide clear and accurate regulatory information to support business decision-making related to customer orders and spare parts releases.
• •Monitor, analyze, and report on block and release process performance.
• •Collaborate with internal stakeholders to drive effective execution of regulatory release activities.
• •Identify opportunities to simplify, automate, and improve regulatory processes and supporting tools.
• •Represent Regulatory Affairs in order process and shipment review discussions when required.
• •Review product catalogue content for regulatory accuracy and coordinate necessary updates with relevant teams.
• •Support regulatory compliance initiatives and undertake additional responsibilities as assigned.

What You’ll Bring

• •Experience working within a regulated industry, preferably the medical device, healthcare, pharmaceutical, or life sciences sector.
• •Understanding of compliance, quality, and regulatory requirements in a global environment.
• •Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and Teams.
• •Experience working with ERP systems and business processes.
• •Strong attention to detail and a commitment to delivering high-quality work.
• •Excellent verbal and written communication skills with the ability to collaborate effectively across technical and non-technical teams.
• •Ability to manage priorities independently while contributing as an active team member.
• •Proactive, solution-oriented approach to problem solving and process improvement.
• •High level of integrity, professionalism, and accountability.
• •Continuous improvement mindset with the ability to identify and implement practical enhancements.

What You’ll Get

From Day One

• •Private medical care (Medicover)
• •Group life insurance
• •Multikafeteria benefits platform, including access to the Multisport card

After Successful Completion of the Probation Period

• •Employee Pension Plan (PPE)
• •Employee Assistance Program (EAP) offering psychological and legal support
• •Glasses reimbursement
• •Employee discounts platform
• •Employee referral program

Application Process

We look forward to receiving your application. Please submit your CV in English via the Apply button. We review applications on an ongoing basis and encourage early applications.

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.