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Regulatory Affairs Manager

SIRE Life Sciences®

Netherlands, zagranica

SIRE Life Sciences®

Regulatory Affairs Manager

Location: Netherlands

SIRE 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 Biotechnology, Medical Devices and Pharmaceutical organization, based in Netherlands.

Our client is a professional Medical Devices organization, based in Gelderland Netherlands.
Specialist in custom-made quality control solutions for In Vitro Diagnostics. A broad variety of products sold and used in more than 80 countries.

ROLE DESCRIPTION

Immediate position open for an RA Manager that will be responsible for all Regulatory Affairs within the company

RESPONSIBILITIES

- Advising in the interpretation and application of IVD regulations as well as the planning and implementation of new and updated regulations
- Review analytical validation study designs, protocols, data analysis, reports, product labelling including packaging inserts and ensure compliance
- Prepare regulatory submissions for international registrations of new and modified products, including but not limited to FDA 510(k)s, EU IVDD/ERC dossiers, and Health Canada
- Review advertising and promotional materials for regulatory compliance
- Strengthen Regulatory Affairs in the DNA of the organization

REQUIREMENTS

- Bachelors or Masters degree in Science preferably in Life Sciences or Regulatory Affairs related
- Experience in the medical device industry, preferably in in-vitro diagnostics and working knowledge of FDA, EU IVDD and other foreign nation medical device regulations
- Ability to make balanced decisions in relation to business/customer requirements and offer appropriate advice
- Multitasks, prioritizes and meets deadlines
- Very good interpersonal and communication skills with key individuals inside and outside the organization
- Best in class technical writing ability for complex technical file compilation

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

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SIRE Life Sciences®

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