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Senior RA Manager
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 Solothurn Switzerland.
This company is a leading healthcare company and has a high standard of quality and regulatory. They are ISO 13485 and FDA 21 CFR 820 certified.
As Senior RA Manager, you will be subject matter expert of all Regulatory related issues for the company, both for EU market access and for products produced in Switzerland that need to be exported globally. Your position will be based in the Canton of Solothurn.
- Organising and implementing strategies and activities required to procure regulatory approval for new and revised product lines.
- Ensuring compliance to all US, EU and international requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical devices/combination products.
- Applying scientific principles to understanding safety and efficacy on a wide range of products.
- Coordination with the FDA and other regulatory agencies on submissions, approvals and other issues.
- Participating in cross functional team activities from initial stages through securing government approvals for any initiative and project requiring Regulatory Affairs support.
- BSc in Science (ideally you have a RAC certificate)
- At least 4 years experience in the medical devices industry
- Knowledge of FDA and EC MDD regulations
- Experience with 510(k), EU MDD 93/42/EEC/ISO Technical File/Design Dossier preparation
- Experience in successful interaction with FDA and notified body reviewers/inspectors
- Strong communication skills and good team worker
- Fluent in English
- Fluency in German a big asset
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.