Regulatory Affairs professional

Bedrijfsnaam: -
Plaatsingsdatum: 13/04/2019
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 Medical Devices organisation, based in Vlaams-Brabant Belgium.The CompanyThis organisation is an innovative and rapidly growing Medical Device company. They are internationally represented and are currently expanding their markets.

Role DescriptionIn your role as Regulatory Affairs consultant, you will receive the responsibility to support and guide a project with the FDA. You will assist the team, other departments and external stakeholders. You will overview the documentation, participate in inspections, submissions and registrations. Next to that, you are involved in the development of strategic plans and the implementation.

Responsibilities• Key role for Regulatory Affairs for internal and external stakeholders among which authorities and notified bodies
• Support in the administration, submissions and registrations of product documentation
• Supportive and advisory role for the particular project
• Maintenance and controlling of the required regulation standards and legislation
• Leader during internal and external audits from the beginning to the end of the process, and making reports of these audits

Requirements• Bachelor or Master in Life Sciences
• Experience with the MDD and preferably MDR
• Excellent knowledge of CE-marking, FDA and 510 k. Submission
• Experience with inspections, support in audits for both internal and external suppliers
• Excellent writing and verbal skills in English
• Knowledge of the ISO 13485, particularly the 2016 norm
• Strong analytical skills and eye for detail

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
3 - 5 jaar
Contactgegevens :