RA Officer

Bedrijfsnaam: -
Plaatsingsdatum: 02/05/2019
Standplaats: -


SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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 Pharmaceutical, Chemicals and Biotechnology organisation, based in Noord-Brabant Netherlands.The CompanyInternational, rapidly growing organization with plenty of challenges and opportunities for professional and personal development. They are specialized in veterinary products on a global level. It is a booming business where customer relationships are essential!

Role DescriptionFor this company registrations are key to the business. In your role as Regulatory Affairs specialist, your main responsibility is to do registrations for various global markets . You will have a supportive role in creating awareness and exchange of knowledge about international regulations and changes. In addition, you interact with internal and external stakeholders and you will ensure that they are provided with the required information. Next to that, you are involved in the development of strategic plans which are related to the Regulatory Affairs and the implementation.

ResponsibilitiesOn a daily basis you are responsible for the collection and implementation of regulations in relation to the specification of various products. Furthermore, your tasks include:
• Active role in maintenance and (new) product registrations for particular foreign markets
• Supportive role for both internal and external stakeholders about RA related topics
• Development and assessment of the documentation database
• Development and adjustment of strategic plans and assessment of procedures for verification and validation projects
• Supporting execution of evaluation and risk management procedures
• Application and implementation of international legislation and documentation

Requirements• Master or Bachelor
• Minimal 1 year of experience in the pharmaceutical/ biotechnology or medical devices sector
• Minimal 1 year of experience in a RA role
• Preferably knowledge of the international regulations such as Europe and US
• Excellent writing and verbal skills in English and preferably business level understanding of Dutch
• Preferably knowledge of GMP, GDP, ISO 13485, particularly the 2016 norm
• Strong analytical skills and eye for detail
• Team player, yet individual operator

Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Juliette van Kraaij




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
< 1 jaar (starter)
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