Regulatory Affairs Specialist
Location: NetherlandsSIRE® 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.
- Participates in and cooperate with various teams to define regulatory requirements for EU international submissions within the EMEA region.
- Identify guidance documents, international standards, consensus standards and assists teams with their interpretation.
- Prepare regulatory submissions to regulatory authorities.
- Assist with analysis and making recommendations regarding complaints
- Performs other related duties and tasks, as required.
- Industry experience in Medical Devices or Pharmaceuticals
- Knowledge of ISO 13485 and FDA 21 CFR 820 (depending on Regulatory industry experience a preference)
- Strong interpersonal and communication skills -- verbally and in writing -- with others
- Motivated to work within an innovative international medical device organisation where you are able to make a difference!
The Company
They are an international medical device organisation and a leading manufacturer and marketer of disposable medical devices that are used in interventional, diagnostic and therapeutic procedures. They are distributing their products around the world and are expanding at the moment particularly to Eastern European countries. The current challenge here is that many of their products need registration in the new distributed countries and therefore this vacancy of RA specialist.Role Description
In this position you will be responsible for preparing and coordinating regulatory submissions and documentations for the EMEA region. You will do this in cooperation with the RA team located in Maastricht and other offices both in EMEA and Globally. Your primary responsibility is to ensure regulatory compliancy for your assigned (and new) product line. The new RA specialist will have a dynamic job within the organisation where you will as well support recalls, identify requirements and relevant standards for submissions and registrations, assisting with audits, conducting internal audits and assess plus recommend MDD/MDR action course.Responsibilities
Responsibilities will include but not be limited to:- Participates in and cooperate with various teams to define regulatory requirements for EU international submissions within the EMEA region.
- Identify guidance documents, international standards, consensus standards and assists teams with their interpretation.
- Prepare regulatory submissions to regulatory authorities.
- Assist with analysis and making recommendations regarding complaints
- Performs other related duties and tasks, as required.
Requirements
- Strong knowledge of Medical Device regulatory requirements- Industry experience in Medical Devices or Pharmaceuticals
- Knowledge of ISO 13485 and FDA 21 CFR 820 (depending on Regulatory industry experience a preference)
- Strong interpersonal and communication skills -- verbally and in writing -- with others
- Motivated to work within an innovative international medical device organisation where you are able to make a difference!
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