Regulatory Affairs & Quality Lead (Region Europe)

What You’ll Do At Elekta

As Regulatory Affairs & Quality Lead for Region Europe, you will play a critical leadership role in driving regulatory and quality excellence across the region. You will oversee regional regulatory submission strategies, ensure compliance with evolving legislation, and support the development and execution of quality systems aligned with global standards.

You will collaborate closely with regional teams, global stakeholders, and external authorities to enable safe and compliant delivery of Elekta’s products, while continuously improving processes and supporting organizational priorities.

Lead and coordinate regulatory affairs and quality activities across Region EuropeDefine priorities, set expectations, and align regional goals with global strategiesDrive execution of regional regulatory submission strategies and maintain the regulatory roadmapAct as regional coordinator for regulatory submissions and provide guidance on legislation and interpretationRepresent Elekta in interactions with regulatory bodies and industry organizationsSupport local regulatory and quality teams in submissions, compliance, and authority interactionsEstablish, maintain, and improve regional processes, procedures, and quality systemsEnsure deployment of Elekta Quality Policy and adherence to applicable directivesMonitor and report on budget, planning, and logistics for the functionApprove documentation, including regulatory submissions and quality system changesEnsure only compliant products are released for shipmentParticipate in management reviews of regulatory and quality system performanceMentor and develop team members, fostering a high-performing and collaborative environmentDrive continuous improvement initiatives and lead change within the organizationDeputize for the direct manager when required

What You’ll Bring

Proven experience in Regulatory Affairs within the medical device industryStrong knowledge of European medical device regulations; familiarity with US FDA regulations is advantageousExperience working with quality systems, supplier quality, or manufacturing engineeringDemonstrated ability to lead regulatory strategy and translate regulations into business requirementsExperience coordinating submissions and interacting with regulatory authoritiesStrong leadership and team development capabilitiesAbility to influence stakeholders and drive alignment across functionsStructured, problem-solving mindset with knowledge of quality tools and methodologiesExcellent communication skills, both written and verbalHigh level of integrity and ability to build trusted relationshipsExperience managing budgets and operational planningProficiency in Microsoft Office applicationsDegree in engineering or a related field, or equivalent experienceISO Auditor experience is preferredAbility to work effectively in a multicultural, international environment

What You’ll Get

30 paid vacation days per year4 additional Elekta days offDefined contribution pension schemePrivate medical insuranceLunch benefitContribution to wellness activitiesCollaborative office environment with four days per week on-site alongside colleagues

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, so we encourage you to apply as soon as possible. The last day to apply is 25 September.