Regulatory Affairs Engineer

Description:

Elekta is seeking a Senior Regulatory Affairs Engineer to join their team in Crawley. The company is a global MedTech leader focused on precision radiation medicine, dedicated to improving cancer care worldwide.

Key Responsibilities:

• Lead and support global regulatory submissions and approvals for target markets including US FDA, Health Canada, EU MDR, China, Japan, and others.

• Advise on regulatory requirements and integrate them into product and process development.

• Serve as liaison with internal departments and external regulatory authorities.

• Develop and improve regulatory processes for compliance and efficiency.

• Mentor junior team members and contribute to team knowledge and capability development.

• Maintain up-to-date expertise on global medical device regulations and industry trends.

• Provide expert support in audits and inspections, both internal and external.

Requirements / About You:

• Bachelor’s or master’s degree in Engineering, Life Sciences, or related technical field.

• 5+ years of experience in regulatory submissions and project management in the medical device industry.

• Strong working knowledge of FDA, EU MDR, ISO 13485, and other global regulations.

• Ability to interpret complex regulations and implement actionable business practices.

• Excellent written and verbal communication skills in English.

• Strong initiative, integrity, and collaborative mindset.

• Experience in a multi-cultural, cross-functional environment.

• Proficiency in Microsoft Office and ERP systems.

Why Join Elekta:

• Work with an international, innovative team dedicated to improving cancer care worldwide.

• Opportunity for learning, growth, and professional development in a purpose-driven environment.

• Hybrid working flexibility (3 days in office per week).