Clinical Evaluation Lead — MDR Expert (Hybrid)

Key2Compliance AB; Stockholms kommun; Hybrid; SEK 600,000 - 800,000; Full time

Job summary

A leading medical compliance consulting firm is looking for a Clinical Evaluation Consultant in Stockholm. The role involves managing MDR-compliant clinical documentation and collaborating with cross-functional teams to ensure accuracy and compliance. Key qualifications include experience in clinical evaluations and medical writing, with a strong scientific foundation. An MSc or PhD in a relevant field is beneficial, and fluency in English is required. Enjoy a supportive environment that combines structure and entrepreneurial spirit.

Qualifications

• Experience in clinical evaluations and medical writing within the medical device industry.
• Confident in planning and producing MDR-compliant clinical documentation.
• Fluent in English; Swedish is an advantage but not required.

Responsibilities

• Plan, coordinate, and write MDR-compliant Clinical Evaluations.
• Stay up to date with regulatory guidelines, standards, and best practices.
• Communicate effectively with Notified Bodies.

Skills

Clinical evaluations

Systematic literature reviews

Medical writing

Analytical skills

Project management

Education

PhD or MSc in a relevant life science field

Job description

A leading medical compliance consulting firm is looking for a Clinical Evaluation Consultant in Stockholm. The role involves managing MDR-compliant clinical documentation and collaborating with cross-functional teams to ensure accuracy and compliance. Key qualifications include experience in clinical evaluations and medical writing, with a strong scientific foundation. An MSc or PhD in a relevant field is beneficial, and fluency in English is required. Enjoy a supportive environment that combines structure and entrepreneurial spirit.