Junior Specialist Engineering (m/w/d) - Regulatory Affairs KM at LinkedIn

Berlin, Berlin, Germany -

Full Time

Start Date

Immediate

Expiry Date

01 Feb, 27

Salary

45000.0

Posted On

03 Nov, 26

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Hospitals & Health Systems

Description

Support in checking technical documentation for completeness and consistency based on predefined criteria
Participation in the creation and updating of product descriptions as well as work and procedure instructions.
Review and preparation of technical and scientific evidence, including biological assessments, chemical characterizations, toxicological evaluations, literature searches and test results.
Participation in risk analyses, taking into account the quality management system as well as national and international standards and requirements, in coordination with the project management.
Support with risk analyses for changes, CAPAs, complaints and customer inquiries, as well as with the coordination of external investigations and consulting services.
Participation in the planning and evaluation of usability assessments as well as in the regulatory evaluation and documentation of newly included materials.
Preparation of technical and scientific evidence, including documentation on biological assessments, chemical characterizations and toxicological evaluations, according to professional specifications.
Support in the evaluation of PMS data and in the creation or updating of related reports according to technical specifications

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Responsibilities

Support in checking technical documentation for completeness and consistency based on predefined criteria
Participation in the creation and updating of product descriptions as well as work and procedure instructions.
Review and preparation of technical and scientific evidence, including biological assessments, chemical characterizations, toxicological evaluations, literature searches and test results.
Participation in risk analyses, taking into account the quality management system as well as national and international standards and requirements, in coordination with the project management.
Support with risk analyses for changes, CAPAs, complaints and customer inquiries, as well as with the coordination of external investigations and consulting services.
Participation in the planning and evaluation of usability assessments as well as in the regulatory evaluation and documentation of newly included materials.
Preparation of technical and scientific evidence, including documentation on biological assessments, chemical characterizations and toxicological evaluations, according to professional specifications.
Support in the evaluation of PMS data and in the creation or updating of related reports according to technical specifications