Europe Regulatory & Quality Lead — Drive Compliance & Quality

Elekta; Stockholms kommun; On-site; SEK 1,213,859 - 1,655,263; Full time

Benefits offered by this job

30 vacation days

4 Elekta days off

Pension - defined contribution

Private medical insurance

Lunch benefit

Wellness activities

On-site collaboration 4 days/week

Job summary

Elekta is seeking a Regulatory Affairs & Quality Lead for Region Europe to drive 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

Qualifications

• Proven experience in Regulatory Affairs within the medical device industry.
• Strong knowledge of European medical device regulations; familiarity with US FDA regulations is advantageous.
• Experience working with quality systems, supplier quality, or manufacturing engineering.
• Demonstrated ability to lead regulatory strategy and translate regulations into business requirements.
• Experience coordinating submissions and interacting with regulatory authorities.
• Strong leadership and team development capabilities.
• Ability to influence stakeholders and drive alignment across functions.
• Structured, problem-solving mindset with knowledge of quality tools and methodologies.
• Excellent communication skills, both written and verbal.
• High level of integrity and ability to build trusted relationships.
• Experience managing budgets and operational planning.
• Proficiency in Microsoft Office applications.

Responsibilities

• Lead and coordinate regulatory affairs and quality activities across Region Europe.
• Define priorities, set expectations, and align regional goals with global strategies.
• Drive execution of regional regulatory submission strategies and maintain the regulatory roadmap.
• Act as regional coordinator for regulatory submissions and provide guidance on legislation and interpretation.
• Represent Elekta in interactions with regulatory bodies and industry organizations.
• Support local regulatory and quality teams in submissions, compliance, and authority interactions.
• Establish, maintain, and improve regional processes, procedures, and quality systems.
• Ensure deployment of Elekta Quality Policy and adherence to applicable directives.
• Monitor and report on budget, planning, and logistics for the function.
• Approve documentation, including regulatory submissions and quality system changes.
• Ensure only compliant products are released for shipment.
• Participate in management reviews of regulatory and quality system performance.
• Mentor and develop team members, fostering a high-performing and collaborative environment.
• Drive continuous improvement initiatives and lead change within the organization.
• Deputize for the direct manager when required.

Skills

Regulatory affairs

Quality systems

Leadership

Regulatory submissions

Stakeholder management

Budgeting & planning

Communication

Multicultural environment

Education

Degree in engineering or related field

ISO Auditor experience preferred

Tools

Microsoft Office

Job description

Elekta is seeking a Regulatory Affairs & Quality Lead for Region Europe to drive 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