Regulatory Affairs Officer
Location: NetherlandsSIRE 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 and Pharmaceutical organization, based in Zuid-Holland Netherlands.
Fast growing Medical Devices company in the region of Rotterdam.
ROLE DESCRIPTION
Set up, maintain and optimize technical documentation for Medical Devices. Making sure that this information reaches international agencies on time with the right quality of documentation.
RESPONSIBILITIES
- Implement, safeguard and monitor the Regulatory Affairs processes
- Realize the registrations of our products in relevant countries
- Interpret and implement international regulations and standards
- Advise on strategy and tactics regarding the submission of technical files
- Monitoring the progress to arrive at a complete technical file
- Conducting literature studies and following up on them
- Contribute to the risk management process
- Drafting and reviewing plans, protocols and reports for, among other things, carrying out verification and validation cases
- Outsourcing work on, among other things, test laboratories with the correct accreditation for supporting documentation and also assessing this documentation
- Advising and supporting stakeholders with regard to statistical substantiation
- Drafting and reviewing various product related documentation
- Answering questions and following up comments from the supervisory authorities in accordance with the companies objectives
- Ensure unity and recognisability in the documentation.
REQUIREMENTS
- Obtaining, maintaining and maintaining CE registrations
- The preparation and final submission of international registrations (FDA is an advantage)
- The current, applicable, international laws and regulations and ISO standards
- The application of the applicable requirements to our product portfolio and to the products under development
- Clinical Evaluation, Usability and Risk management systems and processes
- ISO 13485: 2016
OTHER
Excellent command of the Dutch and English language in word and writing
An accurate and driven work attitude
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.
