European Medical Device CRA – PMS/PMCF Expert

optimed Medizinische Instrumente GmbH; Germany (OH); Hybrid; USD 58,568 - 81,995; Full time

Job summary

optimed Medizinische Instrumente GmbH is seeking an experienced Clinical Research Associate to oversee post-market clinical studies for neurovascular and peripheral vascular interventional medical devices. This role will ensure compliance with ICH-GCP and EU Medical Device Regulation while managing multiple trial sites in Europe, particularly Germany.

The ideal candidate will have a Bachelor's degree in a relating field, at least 3 years of monitoring experience, and fluency in German and English. The position requires strong organizational skills and a willingness to travel extensively.

Qualifications

• Minimum of 3 years of independent monitoring experience in the medical device or pharmaceutical industry.
• Solid knowledge of EU Medical Device Regulation (MDR), ICH-GCP, ISO 14155.
• Ability to manage multiple sites independently and willingness to travel extensively.

Responsibilities

• Manage site activities for assigned clinical sites in Europe.
• Ensure study conduct complies with approved protocol and GCP.
• Perform source data verification and manage investigational device accountability.

Skills

Fluent in German and English

Strong organizational skills

Problem-solving skills

Team collaboration

Education

Bachelor's degree or higher in Medicine, Pharmacy, Life Sciences

Tools

Electronic Data Capture (EDC) systems

Clinical trial management tools

Job description

optimed Medizinische Instrumente GmbH is seeking an experienced Clinical Research Associate to oversee post-market clinical studies for neurovascular and peripheral vascular interventional medical devices. This role will ensure compliance with ICH-GCP and EU Medical Device Regulation while managing multiple trial sites in Europe, particularly Germany.

The ideal candidate will have a Bachelor's degree in a relating field, at least 3 years of monitoring experience, and fluency in German and English. The position requires strong organizational skills and a willingness to travel extensively.