Hemoteq AG
Project Manager(m/w/x)
Full-timeOn-siteSenior
Würselen
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HEHemoteq AG
Manager Regulatory Affairs(m/w/x)
Würselen
Full-timeOn-siteManagement
Nejo AI Summary
International approval and registration for medical devices, including ETO sterilization validation, in the medical device industry. Medical device industry experience with EU MDR, ISO, and US FDA regulatory knowledge required. Worldwide communication with authorities and suppliers.
Requirements
- Degree in natural sciences, biomedical engineering, or comparable qualification
- Experience in the medical device industry, ideally in validation of sterilization processes (ETO)
- Familiarity with regulatory requirements for medical devices in the EU (EU MDR, ISO standards, MPDG); knowledge of pharmaceutical regulations (AMG, GMP) and international standards (US FDA) advantageous
- Good understanding of medical devices and functional pharmaceutical coatings
- Independence, structured work, and teamwork skills
- Proficiency in MS Office, Adobe Acrobat, and quality management systems according to EN ISO 13485
- Excellent written and spoken German and English skills
Tasks
- Develop Regulatory Affairs and quality management systems
- Coordinate international approval and registration for medical devices
- Prepare and maintain technical documentation
- Communicate with customers, suppliers, and authorities worldwide
- Handle inquiries from regulatory authorities
- Research country-specific approval requirements
- Support R&D, production, and logistics with regulatory compliance
- Maintain change management processes
- Support design and process changes
- Prepare and conduct audits
- Communicate with customers and authorities during audits
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
- Adobe Acrobat
- quality management systems according to EN ISO 13485
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Hemoteq AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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HEHemoteq AG
Manager Regulatory Affairs(m/w/x)
Würselen
Full-timeOn-siteManagement
Nejo AI Summary
International approval and registration for medical devices, including ETO sterilization validation, in the medical device industry. Medical device industry experience with EU MDR, ISO, and US FDA regulatory knowledge required. Worldwide communication with authorities and suppliers.
Requirements
- Degree in natural sciences, biomedical engineering, or comparable qualification
- Experience in the medical device industry, ideally in validation of sterilization processes (ETO)
- Familiarity with regulatory requirements for medical devices in the EU (EU MDR, ISO standards, MPDG); knowledge of pharmaceutical regulations (AMG, GMP) and international standards (US FDA) advantageous
- Good understanding of medical devices and functional pharmaceutical coatings
- Independence, structured work, and teamwork skills
- Proficiency in MS Office, Adobe Acrobat, and quality management systems according to EN ISO 13485
- Excellent written and spoken German and English skills
Tasks
- Develop Regulatory Affairs and quality management systems
- Coordinate international approval and registration for medical devices
- Prepare and maintain technical documentation
- Communicate with customers, suppliers, and authorities worldwide
- Handle inquiries from regulatory authorities
- Research country-specific approval requirements
- Support R&D, production, and logistics with regulatory compliance
- Maintain change management processes
- Support design and process changes
- Prepare and conduct audits
- Communicate with customers and authorities during audits
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
- Adobe Acrobat
- quality management systems according to EN ISO 13485
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Hemoteq AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
Not a perfect match?
- Hemoteq AG
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