Senior Expert Clinical Affairs especially within medical devices environment with clinical experience from projects in many different enterprises
Successfully helped MedTec companies with but not limited to Preparation of clinical evaluation plans and reports according to MDR and MEDDEV, Clinical Study & Clinical Project Management, Clinical Documentation Etc.
Already successfully placed via K-Recruiting with very positive references
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Chemistry, PhD
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Clinical Affairs, Clinical Evaluation, Clinical Documentation, Clinical Project Management, Study Design/Planning, Scientific Analysis, Literature Research, Stakeholder Management, MEDDEV, MDR, GCP, Medical Devices
Key-Facts
Extract from previous activities
Medical Devices Company, Germany
Clinical Affairs Manager
Preparing clinical evaluation plans and reports per MEDDEV 2.7/1 Rev. 4, MDR (EU) 2017/745 & 2017/746, and DIN EN ISO 14155:2021-05; coordinating with a Medical Expert
Selecting literature for the device's intended use, analyzing clinical data, & summarizing results
Independently lead projects and communicate and coordinate with our customers
Medical Device Company, Switzerland
Global Clinical Study Manager
Manage clinical studies, including protocol and database development, site management, and project planning
Reviews and interprets study results and reports
Participates in the development and implementation of the clinical and regulatory strategy
Participate in team meetings to ensure goals, deliverables, issues, decisions, risks, and actions are tracked
Helps develop and update study documents
Medical Device Company, Germany (via K-Recruiting)
Manager Clinical Affairs
Clinical evaluations (MDD, MDR) and risk analyses for various regulatory frameworks
Design and planning of clinical and preclinical studies for regulatory approval
Describe the clinical evaluation & post-market followup plans; review and interpret final study results
Contributes to establishing procedures including SOPs
Medical Device Company, Germany (via K-Recruiting)
Manager Clinical Affairs
Clinical evaluations (MDD, MDR) and risk analyses for various regulatory frameworks
Design and planning of clinical and preclinical studies for regulatory approval
Describe the clinical evaluation & post-market followup plans; review and interpret final study results
Contributes to establishing procedures including SOPs
Medical Devices Company, Germany
Clinical Consultant Medical Devices
Clinical evaluation of various products according to MDD and MEDDEV
Review technical documents and product descriptions for clinical evaluation
Clinical risk management
Design and planning of clinical and preclinical studies for regulatory approval
Implementation of SOPs for standardized work
Medical Devices Company, Switzerland
Clinical Manager
Oversee and contribute to key study documents such as protocols, amendments, study plans, procedure manuals, and reports
Responsible for project development & performance tracking and risk management
Established systems and procedures including SOPs, tracking system, metrics
Provided strategic input to execution of studies and reviews cost and resource projections
Reviews and interprets final study results and reports
Develops and implements trainings
Medical Devices Company, Germany
Clinical Manager
Conduct clinical research per project plan, SOPs, and regulations
Analyze and develop action plans for investigational sites, vendor, and administrative issues
Plan, prepare, and present at Investigator and Research Coordinator Meetings
Provide Quality Assurance support and management level representation during audits and inspections