Scientific Manager – Medical Devices

Jobtailor; Nieder-Olm; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a Medical Affairs specialist to prepare clinical documentation and CERs/PMCF reports in compliance with MDR, MEDDEV, and ISO 13485. You will support R&D, Regulatory, and PLM with scientific guidance and regulatory submissions.

You'll analyze clinical data, review materials for accuracy, and assist audits, product launches, and cross-functional decisions in a MedTech environment. Fluency in German and English is required.

Qualifikationen

• Degree in medicine, natural sciences, life sciences, or comparable qualification.
• At least 3 years of professional experience in Medical Affairs, Medical Science, Clinical Affairs, or Scientific Management.
• Experience preparing CERs and PMCF documentation.
• Knowledge of MDR/MEDDEV regulatory requirements; ISO 13485 desired.
• Experience evaluating scientific literature and analyzing clinical data.
• Excellent scientific writing and clear presentation of complex information.

Aufgaben

• Prepare and maintain clinical documentation per regulatory standards.
• Draft CERs and PMCF reports in line with MDR and MEDDEV.
• Provide scientific advice to R&D, Product Management, PLM, Regulatory Affairs, and Vigilance.
• Collaborate with stakeholders on product development, changes, and regulatory submissions.
• Conduct literature and database searches; analyze clinical data.
• Review marketing and training materials for accuracy and compliance.
• Support audits, inspections, and regulatory inquiries.
• Contribute to clinical strategies and cross-functional decision-making.
• Conduct and support product training and international MedTech seminars.
• Continuously optimize Scientific Management processes.

Kenntnisse

Clinical Documentation

CERs & PMCF

Regulatory Knowledge

Scientific Writing

Literature Review

Data Analysis

Product Training

Cross-functional Collaboration

MS Office

Bilingual EN/DE

Ausbildung

Medicine or Life Sciences degree

Tools

MS Office Suite

Jobbeschreibung

• Prepare and maintain high-quality clinical documentation in accordance with regulatory requirements and scientific standards
• Prepare Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) Reports in accordance with the MDR and MEDDEV guidance
• Provide scientific advice and support to Research & Development, Product Management, Product Lifecycle Management (PLM), Regulatory Affairs, and Vigilance
• Collaborate with internal stakeholders on product development, product changes, and regulatory submissions
• Conduct literature and database searches and analyze and evaluate clinical data
• Review and approve marketing and training materials for scientific accuracy and compliance
• Support audits, inspections, and regulatory inquiries
• Contribute to clinical strategies, scientific evaluations, and cross-functional decision‑making processes
• Conduct and support product training, product launches, and international MedTech seminars
• Continuously optimize processes, methods, and standards in Scientific Management

Requirements

• Degree in medicine, natural sciences, life sciences, or a comparable qualification
• At least 3 years of professional experience in Medical Affairs, Medical Science, Clinical Affairs, or Scientific Management
• Experience preparing clinical documentation, particularly Clinical Evaluation Reports (CERs) and PMCF documentation
• In-depth knowledge of regulatory requirements for medical devices, particularly the MDR and MEDDEV guidance; knowledge of ISO 13485 is desirable
• Experience evaluating scientific literature and analyzing clinical data
• Excellent scientific writing skills and the ability to present complex information clearly and accessibly
• Knowledge of tracheotomy, tracheostomy tube management, ventilation, or related medical fields is an advantage
• Proficiency in MS Office (Word, Excel, PowerPoint)
• Excellent written and spoken German and English, at least C1 level
• Ability to collaborate across departments and interact professionally with internal and external stakeholders

Core Competencies

Demonstrates expertise in preparing Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) documentation while ensuring compliance with MDR and MEDDEV guidance. Proficient in scientific writing and data analysis, with strong collaboration skills across departments and stakeholders.

Highest-signal resume keywords

• Clinical Evaluation Reports (CERs)
• Post-Market Clinical Follow-up (PMCF) Documentation
• Regulatory Requirements (MDR, MEDDEV)
• Scientific Writing Skills
• MS Office Proficiency

Hard Skills

• Clinical Documentation Preparation
• Data Analysis
• Scientific Evaluation
• Regulatory Submissions
• Process Optimization
• Literature Review
• Clinical Data Evaluation
• Product Training
• Medical Affairs Experience
• Clinical Affairs Experience

Soft Skills

• Collaboration
• Professional Interaction
• Clear Communication

Industry Keywords

• Medical Devices
• ISO 13485
• Tracheotomy
• Tracheostomy Tube Management
• Ventilation
• Scientific Management
• Regulatory Affairs
• Product Lifecycle Management (PLM)
• Vigilance
• Cross-Functional Decision-Making