Fluid Registration RA Officer
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 Biotechnology and Medical Devices organization, based in Zuid-Holland Netherlands.
Middle sized manufacturing company in the area of Opthalmology.
As a liquid registration RA Officer , you support in the development of fluid products by the transfer of management with regard to the necessary documentation. You carry out review and approval of all documentation necessary to bring the liquid products on the international market . You warrant that products timely receive the required regulatory approval on the basis of the applicable registration requirements. You anticipates ongoing requirements applicable standards and registration so that these products can be produced according to these standards and requirements and can be delivered worldwide. You will report directly to the QA Manager and functionally to the Strategic Product Management Director fluids and works closely with the Project Manager fluids.
- Responsible for giving advice, conducting the review and approval of the project plan for new or changing liquid products;
- See to it that all project documentation is completed in accordance with applicable laws and regulations for medical devices and pharmaceutical products;
- Is also responsible to carry out the advice, review and approval tasks of the project in accordance with the timetable;
- Supporting the project manager fluids when creating the project and report periodically on the progress of the assigned tasks;
- To identify and clarify the organization which admission requirements and standards in force in the different countries or regions;
- Maintaining contact with the relevant regulatory authorities in respect of registrations;
- Analysing and anticipating the current medical standards and amendments thereto, so that the delivered products meet the applicable (inter) national regulations (eg, 510 (k), PMA, establishment and product listings, etc.).
- HBO / WO education Biotechnology , (bio) pharmacy or chemical (technology) ;
- Experience with (inter) national legislation in the field of medical devices or pharmaceuticals ;
- 3-5 years of relevant experience in a multidisciplinary project in a production environment ;
- Good command of English both written and spoken ;
- Knowledge of Directive 93/42 / EEC concerning medical devices, and the applicable laws and regulations of various countries ;
- Good knowledge of sterilization and sterility , Bio compatibility and clinical evaluation.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.