Regulatory Affairs Officer Vloeistof

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 Medical Devices organization, based in Zuid-Holland Netherlands.

Developer and manufacturer of high quality Medical Devices

ROLE DESCRIPTION

The Regulatory Affairs Officer Liquids supports the projects for liquid products through guiding the project team to generate the required documentation. You perform the review and approval of all documentation that is needed to allow for the liquid products to be marketed worldwide. You ensure that these products receive a timely approval from the applicable regulatory authorities based on the current regulatory requirements.
You continuously anticipate on applicable standards and legislation such that these products can be manufactured according to the applicable standards and legislation and can be marketed worldwide. Hierarchically you report to the QA/RA Director and functionally to the Strategic Product Management Director Liquids and you work closely together with the Project Manager Liquids.

RESPONSIBILITIES

- Responsible for giving advice, performing the review and approval of the project plans for new liquid products or changes to existing liquid products;
- Ensures that all project documentation is delivered according to the applicable law and legislation for medical devices and pharmaceutical product;
- Is also responsible for timely execution of the advice, review and approval tasks;
- Supports the project manager liquids in generating the project planning and reports periodically on progress of the assigned tasks;
- Evaluates which registration and quality system requirements there are per specific country and region;
- Keeps contact with the applicable regulatory authorities and or distributors in case of ongoing registrations;
- Analyze and anticipate on applicable medical and pharmaceutical standards and requirements such that the supplied products are conforming to the applicable (inter)national requirements (for instance: 510(k), PMA, establishment and product listings, etc.).

REQUIREMENTS

- Bachelor or University degree in Biotechnology, (bio)pharmacy, chemistry or chemical technology;
- Experience with international medical/pharmaceutical law and legislation;
- 3-5 years relevant experience in a multidisciplinary project team in a production environment;
- Excellent English language skills both verbal and in writing;
- Knowledge ofthe EU medical device directive and pharmaceutical law and legislation;
- Solid knowledge on the requirements for sterilization practices, bio compatibility and clinical evaluations.

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