Safety Engineer, Medical Device Risk & Compliance

Elekta AB; Crawley; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Up to 25 paid vacation days

Holiday Purchase Scheme

Private Medical Insurance

Employer Pension Contribution Package

Cycle to work scheme

Life Assurance

Onsite restaurant

Job summary

Elekta is a global leader in precision radiation therapy, dedicated to improving cancer care. We seek a professional to lead risk management activities across the product lifecycle, ensure regulatory compliance, and collaborate across cross-functional teams to embed safety into design and development.

The role supports post-market monitoring and continuous improvement in a highly regulated environment. Applicants should have a degree in Engineering or Life Sciences and hands-on experience with

Qualifications

• A degree in Engineering, Life Sciences, or a related discipline, or equivalent practical experience.
• Experience in product safety, risk management, or a related discipline within the medical device industry.
• A good understanding of risk management principles and how they are applied throughout the product lifecycle.
• Knowledge of medical device regulations and the requirements of working in a highly regulated environment.
• Experience interpreting and applying relevant standards and regulations, including ISO 13485, ISO 14971, IEC 60601, IEC 61508, IEC 62304, FDA, NMPA, and MDR requirements.
• Strong communication and collaboration skills, with the ability to work effectively across a range of teams and stakeholders.

Responsibilities

• Lead and support product risk management activities throughout the product development lifecycle.
• Identify potential risks, assess their impact, and ensure appropriate measures are in place to reduce risk to acceptable levels.
• Review and document risk management activities, providing clear recommendations to support product release decisions.
• Ensure products and processes meet relevant regulatory and risk management requirements.
• Work collaboratively with cross-functional teams to embed safety and risk awareness into product design and development.
• Prepare and maintain key risk management reports and monitoring activities, including post-market reviews and ongoing product assessments.

Skills

Product risk management

Regulatory compliance

Cross-functional collaboration

Risk assessment

Communication skills

Education

Engineering degree

Life Sciences degree

Job description

Elekta is a global leader in precision radiation therapy, dedicated to improving cancer care. We seek a professional to lead risk management activities across the product lifecycle, ensure regulatory compliance, and collaborate across cross-functional teams to embed safety into design and development.

The role supports post-market monitoring and continuous improvement in a highly regulated environment. Applicants should have a degree in Engineering or Life Sciences and hands-on experience with