Regulatory Affairs | Junior
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 Zuid-Holland Netherlands.
- Identify Regulatory Issues and strategies concerning Medical Devices, in the scope of the Project, report them to the relevant RA Leaders, investigate and suggest solutions to resolve them
- Support for One Medical Devices organizations in the Netherlands and Belgium related to the Project
- Provide Regulatory support to ensure consistent collaborations with franchises and EMEA/Regulatory Affairs, act as a main contact person
- Handle all necessary activities for the release of SKU codes restrictions
- Collaborate with local teams to ensure flawless completion of the Project an related activities
- Project management
- Able to analyze, interpret and synthesize regulation and guidelines
- Work in parallel environments
- Ability to build internal and external partnerships
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.
The Company
With a strong will to care for the world, one person at the time, inspired and united the people of this company for over 130 years. Embracing research and science bringing innovative ideas, products and services to advance health and well-being of people.Role Description
Within this role you will ensure compliance with local regulatory requirements and the national and international guidelines. You will collaborate with manufacturers, Authorized Representatives and Global Teams, regarding Dutch and Belgian legislation and related requirements.Responsibilities
- Ensuring Regulatory compliance of Medical Devices for their access to the market of the Netherlands, Belgium and Luxembourg- Identify Regulatory Issues and strategies concerning Medical Devices, in the scope of the Project, report them to the relevant RA Leaders, investigate and suggest solutions to resolve them
- Support for One Medical Devices organizations in the Netherlands and Belgium related to the Project
- Provide Regulatory support to ensure consistent collaborations with franchises and EMEA/Regulatory Affairs, act as a main contact person
- Handle all necessary activities for the release of SKU codes restrictions
- Collaborate with local teams to ensure flawless completion of the Project an related activities
Requirements
- Minimum Master in a relevant field- Project management
- Able to analyze, interpret and synthesize regulation and guidelines
- Work in parallel environments
- Ability to build internal and external partnerships
Other information
For this position it is beneficial to have some industry experience in a Medical Device or Pharmaceutical companyAre you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.
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