Regulatory Affairs Specialist

Elekta

Clinical and Theoretical Areas

Veenendaal, Utrecht - Niederlande

Senior Specialist / Project Manager

Hybrid

Experteer Overview

In this role you ensure market access for regulated medical devices by coordinating regulatory submissions and responses with local and global teams. You will help define and improve compliant, quality-focused processes. You’ll drive change initiatives and provide practical solutions to business challenges. This position blends regulatory expertise with cross-functional collaboration to support Elekta’s mission to improve cancer care. You’ll work in a hybrid setup in the Netherlands, contributing to impactful outcomes for patients and healthcare professionals.

Compensation / Benefits

27 paid vacation days per year plus 13 ATV days
Global bonus plan or Profit scheme
Travel allowance
Good pension fund Metalektro, 50/50 payment
Insurance discounts
Hybrid work option (on-site at least 3 days/week)

Responsibilities

Prepare and release regulatory submissions to governing agencies
Collaborate with cross-functional teams to define processes and identify system impacts
Authorize documents and forms related to regulatory activities
Plan and execute audits, including preparation of audit reports
Issue and update processes and procedures
Provide timely and accurate project reports
Drive change and continuous improvement initiatives
Offer creative solutions and proposals to solve business challenges
Align priorities and manage change effectively
Commit to quality and integrity in all aspects of work

Key requirements

Proven experience in Regulatory Affairs for Medical Devices
Strong understanding of product regulation and ability to translate into business requirements
Structured problem-solving skills and a proactive mindset
Excellent communication skills—written and verbal
Ability to work independently and influence cross-functional teams
Proficiency in Microsoft Office applications
Comfortable working in a multicultural environment
Positive attitude towards changes and collaboration

communication proactiveness independence Regulatory affairs for medical devices Regulatory submissions Audit planning and execution

Description

In this role you ensure market access for regulated medical devices by coordinating regulatory submissions and responses with local and glob…

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