Extremely high skilled in all regulatory aspects for medical device industry on national and international level
Very broad experience in different kinds of medical devices (active & non-active, sterile & non-sterile) in all risk classes (I, Is, IIa, IIb, III)
Combines leadership skills as project manager and technical lead with operational excellence for e.g. technical documentation & clinical evaluation
Offers solution-focused services for Start-Ups, small and medium sized enterprises and established companies
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Our content and services may vary by location.
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Overview
- Availability
- Asap, up to fulltime, onsite & remote
- Qualification
- State examination Human Medicine
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Medical Devices, Regulatory Affairs, MDR Readiness, Quality Management, Clinical Operations, Project Management, Technical Documentation, DHFs, Clinical & Biological Evaluation, NB Contact
Key-Facts
Extract from previous activities
Medical Device Company, Germany
Regulatory Affairs Specialist
Supported technical documentation for MDR compliance, focusing on clinical & biological evaluations for medical devices in risk classes Ila and Ilb
Assisted in regulatory affairs for disinfectants, ensuring adherence to industry standards and regulations
Collaborated with cross-functional teams to ensure product compliance and safety measures were met
Medical Device Company, Germany
Technical Expert MDR Remediation
Local Project Management of MDR Remediation
Implementation of the results of a completed gap analysis of the technical documentation / DHF for class IIb / III medical devices
Make additions and changes to the documentation / creation of summary documents
Support in the generation of new documents based on measurements that need to be initiated and maintained
Coordination with departments involved in the documentation
Ensuring documentation compliance in accordance with MDR and 21 CFR 820
Storage of the documentation in a PLM system
Directing documentation to relevant departments
Support in change management with Trackwise 8
Assisting with the creation of documents as part of adapting to a new internal risk management procedure
Medical Device Company, Germany
Senior Regulatory Affairs Manager
Creation, update and maintenance of technical documentation / design dossiers / STED files in the area of hospital products
The Hospital Products business unit manufactures products that are used in the delivery of fluids and medicines across all areas of patient care, both in hospitals and in the home care sector. These are application sets, pre-mixed drugs, reprocessing systems, IV nutritional products, infusion pumps, cytostatics, surgical biomaterials and inhalation anesthetics
Document Management of the RA Documentation
Change Control
Contact to Notified Bodies (TÜV Süd, BSI)
MDR GAP analysis
MDR certification strategy development
Medical Device Company, Germany
Regulatory & Clinical Affairs
Clinical Evaluation according to MEDDEV 2.7/1 rev.4 for the full spectrum of Medical Devices from class I to class III, active and non-active Medial Devices
Coordination of project with internal and external partners
Interpretation of study results/ Post marketing surveillance data and professional integration into the medical- therapeutic context
Project-Controlling and -Management
Process Development
Process and Product Risk Analysis and Management Assisting with the creation of documents as part of adapting to a new internal risk management procedure
Preparation of registration documents outside of the European Economic Area with a focus on the Middle East including North Africa, Asia Pacific, Eastern Europe and South America.