Senior Regulatory Affairs Consultant
Location: AustriaSIRE 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!
THE COMPANY
Our client is a professional Medical Devices organization, based in Wien Austria.
They produce a highly innovative Class III device. Currently they have CE marking, but they would like to expand as well to the USA and China.
ROLE DESCRIPTION
In this role, you will be responsible for all Regulatory Affairs for this company. You will make sure that filings are done correctly and that the device will be allowed to enter new markets. You will be the main communication point between the company and the worldwide regulatory bodies. The company currently has all the resources in house for Clinical, Technical, Quality and Operational processes, but is missing a person solely dedicated to Regulatory Affairs.
It would be highly advantageous if this person would be able to be on-site in Vienna. It would be a role for 2-3 days a week.
RESPONSIBILITIES
- Full Regulatory Affairs planning
- Responsible for all filings (EU, USA and China)
- Guiding of all RA
- Manage all post-market clinical follow-up programs
REQUIREMENTS
- Previous Class III RA experience
- At least 10 years of RA medical devices experience, or related experience
- Hands-on mentality
- Able to work in start-up environment
- Fluent in English
- Fluency in German would be a big plus
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.
