Medtech expert with in-depth knowledge of regulatory affairs and quality management
Deep knowledge of relevant regulations for the EU and US markets (MDR, FDA, ISO 13485 and IEC 62304, ISO 14971 incl. BioKomp, clinical evaluation and usability
Very good experience in digitization of quality systems and product documentation
Top Business Development and Partner Management consultant
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Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Diploma in Equipment Design
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Business Development, Partner Management, Regulatory Affairs, Quality Management, MDR, FDA, Product Owner, ALM, PLM, e-Health, IT, Medtech
Key-Facts
Extract from previous activities
Software Company, Germany
Partner Manager and Business Development
Development and implementation of the partner channel strategy
Services and solutions for ALM and QMS customers to support
Support of innovations in the field of medical technology product development and process management
Focus areas: Regulatory compliance, business innovation, digital transformation, MDR, FDA, cyber security, quality management
Software Company, Germany
Product Owner
Leading the development of an ALM and QMS software platform for medical device manufacturers with a focus on start-ups and complex development projects.
Main focus: Agile methodology, product management, technical documentation, MDR, ISO 13485, ISO 14971, IEC 62304, FDA regulations
Medtech Company, Germany
Senior Manager MedTech & eHealth
Leading the development and documentation staff in complying with regulations and quality assurance for MedTech projects
Implementation of a digital ALM/PLM system for the product development of medical devices as a service
Focus areas: Embedded systems, IoT, business development for medical devices, regulatory affairs EU and USA, quality management
Telemedicine Company, Germany
Manager Business Development & Quality Management
Development of telemedical business models, management of digital product documentation, introduction and management of a quality system for the development and manufacture of medical products as and with software
Main focus: Telemedicine, eHealth, agile software development, ISO 13485, IEC 62304, data migration, quality management and regulatory affairs for active medical devices under MDD/MDR