Regulatory Affairs Specialist

Bedrijfsnaam: -
Plaatsingsdatum: 03/11/2018
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 Limburg Netherlands.The CompanyThis organisation has an extensive portfolio of Medical Devices. Their products vary from endoscopy to interventional oncology. They are internationally represented and currently experience a growth for their EMEA site.

Role DescriptionIn your role as Regulatory Affairs consultant, you will receive the responsibility to support and guide a project within the Middle Eastern Region. You will advise the team, other departments and external stakeholders. You will overview the documentation, participate in inspections, submissions and registrations of various products. 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, transportation, 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 transition of the MDD to the MDR
• Excellent knowledge of CE-marking, 510 k. Submission, Canada Health
• Preferably experience with submissions and registrations in Middle-Eastern, Eastern-European or North African countries
• 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 :