Specialist Technical Documentation Medical devices (m/f/d)
Job details
About Us Riester, part of the global Halma Group, is a leader in medical technology, specializing in diagnostic devices for primary and hospital care. Headquartered in Jungingen, Germany, with regional offices in the USA and Brazil, we pride ourselves on innovation, quality, and a strong global distribution network reaching over 150 countries. About the Role To strengthen our R&D team, we are seeking an experienced Technical Documentation Specialist (m/f/d) who is passionate about advancing the creation and optimization of technical documentation processes, while contributing hands-on to the development and refinement of critical documents. By applying your expertise in regulatory requirements and process optimization, you will drive the creation of comprehensive and compliant technical documentation. Responsibilities
- Take ownership of the creation, maintenance, and optimization of Technical Documentation (TD) in compliance with MDR requirements.
- Actively contribute to the hands-on development of documentation , ensuring accuracy, completeness, and compliance.
- Manage and coordinate the transition of product files from MDD to MDR.
- Support product development projects by ensuring the creation of comprehensive and compliant Product Dossiers.
- Identify and implement improvements in the format, structure and content of existing Technical Documentation.
- Drive the digitization of Technical Documprentation processes.
- Collaborate closely with R&D and Quality Management teams to meet regulatory requirements.
- Train and advise colleagues on all topics related to Technical Documentation.
- Monitor and ensure adherence to international standards and guidelines (e.g., ISO 13485, MDR).
- A degree in a technical, scientific, or related field.
- Several years of professional experience in creating and maintaining Technical Documentation in the medical device industry, including under MDR regulations.
- Solid knowledge of regulatory requirements, particularly MDR and ISO 13485.
- Participation in a transition project to bring technical files from MDD to MDR
- Proven expertise in streamlining documentation processes and implementing digital solutions.
- Structured, solution-oriented with strong analytical skills and a team-oriented approach .
- Excellent communication skills and experience in training colleagues .
- Fluency in German and English , both written and spoken.
- Flexible working hours with remote work options
- A friendly, diverse, and international work environment with flat hirarchies
- 30 days of annual leave
- Access to training and development
- Team events and a welcoming office stocked with fresh fruit and coffee
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