Reg Affairs Specialist
Location: BelgiumSIRE 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 and Pharmaceutical organization, based in Brussel Belgium.
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 company
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.
