Europe Regulatory & Quality Lead — Drive Global Compliance

Elekta AB; Stockholms kommun; Hybrid; SEK 800,000 - 1,100,000; Full time

Benefits offered by this job

Vacation days

Elekta days off

Pension plan

Medical insurance

Lunch benefit

Wellness activities

Hybrid work

Job summary

Elekta AB in Sweden seeks a Regulatory Affairs & Quality Lead for Region Europe to drive regulatory and quality excellence. You will oversee regional submission strategies, ensure compliance with evolving legislation, and support global quality systems aligned with standards.

You will lead cross‑functional teams, coordinate regulatory activities, and mentor staff while representing Elekta with regulatory authorities across Europe. This role demands strong leadership and a strategic mindset.

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.
• Excellent communication skills, both written and verbal.
• Ability to work effectively in a multicultural, international environment.
• ISO Auditor experience is preferred.
• Degree in engineering or related field, or equivalent experience.

Responsibilities

• Lead regulatory 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 leadership

Regulatory strategy

Quality systems

Stakeholder influence

Budgeting & planning

Team development

Communication skills

Multicultural environment

Education

Engineering degree or related field

Equivalent experience

Tools

Microsoft Office

Job description

Elekta AB in Sweden seeks a Regulatory Affairs & Quality Lead for Region Europe to drive regulatory and quality excellence. You will oversee regional submission strategies, ensure compliance with evolving legislation, and support global quality systems aligned with standards.

You will lead cross‑functional teams, coordinate regulatory activities, and mentor staff while representing Elekta with regulatory authorities across Europe. This role demands strong leadership and a strategic mindset.