Regulatory Affairs Specialist
Location: BelgiumSIRE® 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 Pharmaceutical organisation, based in Bruxelles-Capitale Belgium.
• Participant and support third party efforts (e.g. participate in discussions/review with Notified Body)
• Identify priorities and key issues in complex situations, and solves these problems with minimal assistance.
Scientific/Technical Analysis
• Provide support to project teams in the area of design and analysis for more straightforward projects.
• Understand and identify potential flaws and implications and coach the team on tradeoff decisions.
Submission/Project Management
• Lead the preparation, planning, coordination, execution, and ongoing maintenance of regulatory submission.
• Communicate submission quality standards and requirements to project teams.
• Serve as the regulatory expert on cross-functional teams to ensure quality dossier.
• Identify potential risks in submissions and appropriately communicate.
Internal and External Influence and Advocacy
• Interpret existing regulations and guidance documents within regulatory department and on project teams.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.
The Company
The companies employees around the globe are connected by a strong commitment to save and sustain lives. Binding them as a company in doing work that matters.Role Description
As a Reg. Affairs Specialist you will find the perfect mix between quality and result-focus and find challenge in working on Middle Eastern cases.Responsibilities
Strategic Planning and Problem Solving• Participant and support third party efforts (e.g. participate in discussions/review with Notified Body)
• Identify priorities and key issues in complex situations, and solves these problems with minimal assistance.
Scientific/Technical Analysis
• Provide support to project teams in the area of design and analysis for more straightforward projects.
• Understand and identify potential flaws and implications and coach the team on tradeoff decisions.
Submission/Project Management
• Lead the preparation, planning, coordination, execution, and ongoing maintenance of regulatory submission.
• Communicate submission quality standards and requirements to project teams.
• Serve as the regulatory expert on cross-functional teams to ensure quality dossier.
• Identify potential risks in submissions and appropriately communicate.
Internal and External Influence and Advocacy
• Interpret existing regulations and guidance documents within regulatory department and on project teams.
Requirements
• Degree in engineering or life sciences. 3-5 years of experience preferably in Regulatory Affairs, Quality Assurance R&D or System, Standard Compliance testing in a medtech companyAre you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.
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