Project engineer elektra Vacatures in Utrecht

Over de vacature

Overview

Senior Regulatory Affairs Engineer (Team Lead) at Elekta enables global market access for medical devices. You combine hands-on regulatory expertise with a coordinating role, supporting the team to ensure compliance and continuous improvement. You collaborate with cross-functional teams through the product lifecycle to meet international regulatory requirements. You lead and mentor colleagues, liaise with authorities, and drive process optimization in a dynamic, international setting. This role offers the chance to impact cancer care accessibility and quality on a global scale.

Arbeidsvoorwaarden / Benefits

• 27 paid vacation days per year
• 13 ATV days
• Global bonus plan or Profit scheme
• Travel allowance
• Good pension fund 50/50
• Insurance discounts

Verantwoordelijkheden

• Ensure and maintain regulatory approvals and compliance across targeted markets
• Prepare and submit regulatory documentation to governing authorities
• Translate regulations into clear business requirements
• Collaborate with cross-functional teams across the product lifecycle
• Act as a senior point of contact and support and guide team members in day-to-day activities
• Liaise with regulatory authorities and internal stakeholders
• Drive continuous improvement and process optimization
• Authorize regulatory documents and support audits and reporting

Belangrijkste vereisten

• 5+ years' experience in Regulatory Affairs (medical devices)

• Experience with regulatory submissions and project management

• Master's degree in Engineering, Science, or similar

• Strong knowledge of global regulations

• Experience supporting, guiding, or mentoring colleagues in a team setting

• Excellent communication skills in English

• Proactive, structured, and detail-oriented

• communication

• mentoring/leadership

• proactivity

• regulatory submissions

• project management

• global regulatory knowledge

Over de vacature

Overview

Senior Regulatory Affairs Engineer (Team Lead) at Elekta enables global market access for medical devices. You combine hands-on regulatory expertise with a coordinating role, supporting the team to ensure compliance and continuous improvement. You collaborate with cross-functional teams through the product lifecycle to meet international regulatory requirements. You lead and mentor colleagues, liaise with authorities, and drive process optimization in a dynamic, international setting. This role offers the chance to impact cancer care accessibility and quality on a global scale.

Arbeidsvoorwaarden / Benefits

• 27 paid vacation days per year
• 13 ATV days
• Global bonus plan or Profit scheme
• Travel allowance
• Good pension fund 50/50
• Insurance discounts

Verantwoordelijkheden

• Ensure and maintain regulatory approvals and compliance across targeted markets
• Prepare and submit regulatory documentation to governing authorities
• Translate regulations into clear business requirements
• Collaborate with cross-functional teams across the product lifecycle
• Act as a senior point of contact and support and guide team members in day-to-day activities
• Liaise with regulatory authorities and internal stakeholders
• Drive continuous improvement and process optimization
• Authorize regulatory documents and support audits and reporting

Belangrijkste vereisten

• 5+ years' experience in Regulatory Affairs (medical devices)

• Experience with regulatory submissions and project management

• Master's degree in Engineering, Science, or similar

• Strong knowledge of global regulations

• Experience supporting, guiding, or mentoring colleagues in a team setting

• Excellent communication skills in English

• Proactive, structured, and detail-oriented

• communication

• mentoring/leadership

• proactivity

• regulatory submissions

• project management

• global regulatory knowledge