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Sr. RA Manager - Freelance - Meddev
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Medical Devices organization, based in Genf Switzerland.
Our client is a Medical Device Company in the French part of Switzerland
· Project Management
Project objective: planning, development, leading and execution
Planning of all relevant activities that are necessary to achieve project target
Communication and coordination within the team
Planning and coordination of external service providers, e.g. laboratories, if needed
Periodic reporting to Steering Committees
Documentation of the project, such as project planning, reports, minutes, etc.
· Regulatory Affairs
Make sure that the Technical File has proper and adequate structure and it links to all needed evidences
Support other functions (e.g R&D, Manufacturing) to produce or re-mediate missing/incomplete evidences (Specification, Test Plans, Test reports, design transfer..)
Create and assure correct trace-ability (from Design input to Test cases to Design transfer)
Review documents for compliance with Standard and Regulations, GDP, completeness and suitability of the technical contents and of the technical file for CE marking
Ensure the correct product configuration management
Advice on proper device classification and applicable standards and provide guidance
Supported by other functions ensure that risk management evidences are adequate and properly linked to Technical File
Expected Areas of Competence (i.e. KSAs)
Full working knowledge of and significant level of experience with product development including project management including all relevant cross-departments
Ability to develop large scale project schedules, and to assess and manage cross functional team’s progress on assignments relative to project schedule
Professional, concise, tactful and sensitive in communications. Accomplishes objectives when communicating with internal personnel, and external customers and vendors. Able to diplomatically negotiate with a requester concerning design, process, scope or timetable.
Demonstrated good written and verbal communication skills including presentation skills in French and English
Microsoft Office Suite and Project
Sound RA experience in MDD (including knowledge of Meddevs)
Good knowledge of ISO 13485
Very good understanding and hands on experience on Design Control and Technical File for Class I and II medical device
Knowledge of basic standards for medical electrical equipment (EN 60601-1, EN 60601-1-2, EN 60601-1-6, EN 62304, EN 62366)
M.S. degree in one of the following engineering disciplines: Mechanical Engineering, Electronic Engineering, Mechanical Engineering Technology, Biomedical Engineering, Biomedical Engineering Technology.
At least 8 years of experience in RA for medical device (Class I and II)
At least 5 years of experience in project management in international environment
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.