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 organization, based in Zuid-Holland Netherlands.
They are a global company with headquarters stationed in the Netherlands. They focus on Ophthalmic devices to enhance and provide eye surgery and solutions.
ROLE DESCRIPTION
Due to a fall out of one of the employees they are in need of a new regulatory affairs officer to support the RA and QA team in within the company. Your tasks will focus complaint handling regarding all products of the company. As the new regulatory affairs officer you will as well take on the task of the documentation of the Quality Management Systems and supporting the Quality Awareness within the company regarding regulations and procedures.
RESPONSIBILITIES
• Coordinate the investigations of complaint handling and other post market surveillance activities (PMS) regarding company products
• Initiating corrective and preventive actions if complaints start repeating itself. You will coordinate these actions as being responsible for not receiving the same complaints again
• Managing periodic meetings and reports regarding PMS and report to RA Manager when needed in case of major complaints
• Supporting the QA manager in altering procedures in order to improve current processes and prevent mistakes/complaints
• Taking initiative in improvement of company complaint handling as taking end –responsibility
REQUIREMENTS
• HBO/Bachelor degree with preferred background in engineering/sciences
• At least 5 years in medical device background is a pre
• Fluent in English and Dutch
• Experienced in MS Excel
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.