Regulatory Affairs & Quality Lead (Region Europe)
Elekta · Stockholm
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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.
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.
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
What You’ll Bring
- 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
- Degree in engineering or a related field, or equivalent experience
- ISO Auditor experience is preferred
- Ability to work effectively in a multicultural, international environment
What You’ll Get
- 30 paid vacation days per year
- 4 additional Elekta days off
- Defined contribution pension scheme
- Private medical insurance
- Lunch benefit
- Contribution to wellness activities
- Collaborative 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.