European Medical Device CRA – PMS/PMCF Expert

Optimed Group; Deutschland; Híbrido; USD 58.568 - 81.995; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Fluent in German and English

Strong organizational skills

Problem-solving skills

Team collaboration

Educación

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

Herramientas

Electronic Data Capture (EDC) systems

Clinical trial management tools

Descripción del empleo

About us

As a global manufacturer of high-quality medical devices, we at optimed are proud to make an important contribution to people’s health every day. Working with us means a conscious desire to take on responsibilities and contribute to a well-functioning team.

To strengthen our international team, we are looking for a

Clinical Research Associate (CRA) – Europe (m/f/d)

We are seeking an experienced Clinical Research Associate (CRA) to support post-market clinical studies for neurovascular and peripheral vascular interventional medical devices across Europe. The role focuses on ensuring clinical trial compliance with ICH-GCP, ISO 14155, EU Medical Device Regulation (MDR), and local regulatory requirements. The ideal candidate will have a strong background in medical device clinical monitoring within Europe, particularly in Germany, and will be capable of independently managing multiple trial sites.

About us

As a global manufacturer of high-quality medical devices, we at optimed are proud to make an important contribution to people’s health every day. Working with us means a conscious desire to take on responsibilities and contribute to a well-functioning team.

To strengthen our international team, we are looking for a

Clinical Research Associate (CRA) – Europe (m/f/d)

We are seeking an experienced Clinical Research Associate (CRA) to support post-market clinical studies for neurovascular and peripheral vascular interventional medical devices across Europe. The role focuses on ensuring clinical trial compliance with ICH-GCP, ISO 14155, EU Medical Device Regulation (MDR), and local regulatory requirements. The ideal candidate will have a strong background in medical device clinical monitoring within Europe, particularly in Germany, and will be capable of independently managing multiple trial sites.

Your Qualifications & Experience:

Essential Requirements:

• Bachelor's degree or higher in Medicine, Pharmacy, Life Sciences, or a related discipline.
• Minimum of 3 years of independent monitoring experience in the medical device or pharmaceutical industry, preferably with exposure to neurovascular, peripheral vascular, cardiology, or interventional device studies.
• Solid knowledge of EU Medical Device Regulation (MDR), ICH-GCP, ISO 14155, and local regulatory and ethics submission processes.
• Ability to manage multiple sites independently and willing to travel extensively.
• Fluent in both German and English (written and spoken), with the ability to communicate complex medical information clearly.
• Strong organizational, problem-solving, and team collaboration skills.

Preferred Qualifications:

• Hands-on experience in post-market clinical studies (PMS/PMCF) or regulatory-focused clinical trials.
• Familiarity with Electronic Data Capture (EDC) systems and clinical trial management tools.

Your contribution to our mutual success:

• Manage site activities for assigned clinical sites in Europe (with emphasis on Germany), including site feasibility, initiation, monitoring, and close-out visits.
• Ensure study conduct complies with the approved protocol, Good Clinical Practice (GCP), ISO 14155, and relevant national regulations.
• Perform source data verification (SDV), review case report forms (CRFs), manage investigational device accountability, and track safety reporting.
• Establish and maintain effective communication with Principal Investigators (PIs), site staff, and clinical research coordinators (CRCs) to ensure study progress and data quality.
• Prepare monitoring visit reports, track study progress, identify risks and issues, and contribute to resolution plans.
• Support essential document preparation, submission to ethics committees and competent authorities, and contract negotiation processes.
• Collaborate cross-functionally with Medical Affairs, Data Management, Biostatistics, and Regulatory Affairs teams to achieve study milestones.