Clinical Reviewer MDR/IVDR (f/m/d)

CSA Group; Plattling; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

CSA Group Europe is seeking a Clinical Reviewer MDR/IVDR to join the Healthcare Regulatory Services Team. The successful candidate will be responsible for clinical assessments of medical and in vitro diagnostic devices, ensuring compliance with EU regulations while supporting and training clinical assessors.

Leistungen

Flexible working hours

Work-from-home options

Training opportunities

Health programs

Lease a bike

Pension plans

Corporate benefits

Qualifikationen

• Minimum of 5+ years of relevant clinical experience.
• Profound knowledge of EU regulations (EU 2017/745 and 2017/746).
• Ability to manage multiple evaluations and deadlines effectively.

Aufgaben

• Ensure assessments address regulatory responsibilities and maintain clinical assessment procedures.
• Develop training for clinical assessors and oversee reviews of clinical data assessments.
• Represent CSA Group at congresses and conferences as a speaker on clinical topics.

Kenntnisse

Interpersonal skills

Decision-making skills

Organizational skills

Communication skills

Ausbildung

University degree in medical or scientific fields

Jobbeschreibung

Employment Status: Regular

Time Type: Full time

Job Summary:

CSA Group Europe has an opportunity for a Clinical Reviewer MDR/IVDR (f/m/d) to join our Healthcare Regulatory Services Team in Germany and throughout Europe. The Clinical Reviewer will support the MD/IVD assessment team in the delivery of clinical assessments of products under the European Regulations for Medical and In Vitro Diagnostic Devices.

Responsibilities:

1. Ensure assessments address the regulatory responsibilities regarding clinical performance, aligning with state-of-the-art expectations and risk/benefit analysis. Formulate, maintain, and improve clinical assessment procedures in line with CSA Group and external authority standards.
2. Develop and deliver training to clinical assessors and conduct calibration events for the clinical team.
3. Support the Head of Medical Regulatory Services in demonstrating effective clinical assessment procedures to authorities and review of clinical assessment projects.
4. Oversee and review clinical data assessments performed by internal and external staff for compliance with regulations and norms.
5. Assist the Commercial team in clinical assessment planning and effort estimation.
6. Represent CSA Group at congresses and conferences as a speaker on technical/clinical topics.
7. Qualifications include a university degree in medical or scientific fields or equivalent professional knowledge.
8. Minimum of 5+ years of relevant clinical experience.
9. Profound knowledge of EU regulations (EU 2017/745 and 2017/746), directives, and guidelines for MD/IVD device certification, including MDCGs and Notified Body roles.
10. Experience in evaluation and decision-making for medical and/or IV devices under conformity assessment procedures.
11. Strong interpersonal, decision-making, organizational, and communication skills.
12. Ability to manage multiple evaluations and deadlines effectively.
13. Proficiency in German and English; additional European languages are a plus.
14. Benefits include flexible working hours, work-from-home options, training opportunities, health programs, lease a bike, pension plans, and other corporate benefits.

This job is currently active and accepting applications.