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Compliance Expert

   Back Region: Belgium Kind of contract: Open-ended Work regime: Fulltime Location: BE - Louvain-la-Neuve
Retour Région: Belgium Type de contrat: Open-ended Régime de travail: Fulltime Lieu: BE - Louvain-la-Neuve
Zurück Region: Belgium Art des Vertrages: Open-ended Arbeit Regime: Fulltime Standort: BE - Louvain-la-Neuve
  返回 地区: Belgium 样的合同: Open-ended 工作体制: Fulltime 地点: BE - Louvain-la-Neuve

Job Description

Description de l'emploi

Stellenbeschreibung

工作描述

IBA, as a leader in proton therapy, stays at the forefront of cancer cure by investigating and then implementing new functionalities (e.g. improved workflow or imaging capability), but also new treatment modalities (e.g. arc or flash therapy) in its products. This requires maintaining and further developing experts with excellent knowledge of the regulatory environment and the norms we must comply to. In the context of its development roadmap but also to reinforce the IBA teams in charge of applicable regulations, in various countries, we are currently seeking for a person who will become one of our reference compliance experts.
Challenges we trust you with
You are part of the system architecture team within IBA Innovation & Development department: a team whose expertise covers IBA system-specific knowledge. Your role mainly consists of:
  • taking part to development project teams to advise on compliance-related issues
  • acting as a reference point to establish / review records, procedures and instructions related to compliant design and development activities; you train your colleagues on those matters
  • being proactive and staying up to date with compliance-related practices to suggest evolutions in our processes
  • representing IBA in external committees related to standardization and product compliance.
To fulfill this role, you will use and complement your existing background with a deep knowledge of the IBA proton therapy and radiopharmaceutical product range. You will work in close collaboration with other compliance experts, but also with various other experts and engineers working at IBA.

Profile

Profil

Profil

简介

Hard skills
  • Master’s degree or postgraduate level in Science or Engineering
  • Strong knowledge of medical device regulations aspects related to design and development
  • In-depth knowledge and proven application of IEC and ISO standards for Medical devices design and development. Additional knowledge of standards for other non-medical technologies is a plus
  • Min. 5 years of professional experience in medical device development in a position associated to compliance, risk analysis, requirements engineering or testing
  • Experience in Radiation therapy or related field is a plus as well as experience on a complex electromedical equipment involving software
Soft skills
  • Passionate for details and language accuracy
  • Able to organize your work autonomously and take initiatives
  • Curious and willing to keep on learning and improving.
  • A team player; able to listen, understand, communicate, and convince others
  • Good in negotiations and able to take into consideration different cultures
  • Excellent communicator in English; French is an important asset
  • Willing to travel worldwide (up to 5-10%).

Company

Société

Unternehmen

公司


Offer

Offre

Angebot

聘用意向书

The identity of IBA is characterized by a group of colleagues driven by motivation, curiosity, creativity, the desire to learn on a daily basis, by technical challenges and above all by a highly developed team and family spirit that makes the daily life smoother and more enjoyable!
 
By joining a team of about 40 nationalities and working on more than 45 different sites on 3 continents, IBA offers you the opportunity of a meaningful career with a direct impact in the fight against cancer.​
 
We are driven by: ​
  • Innovating in a cutting-edge technology environment ​
  • Developing professional and personal skills by learning on the Job; by participating in challenging projects; top class courses ​
  • Evolving in a friendly culture environment based upon solid values (dare - share - care - be fair) ​
  • Acting autonomously and belonging to motivated teams with good work-life balance ​
  • Contributing to a company where sustainability, safety and well-being are key to our success
If you are passionate, cause-driven, you can make this quest yours by joining our dedicated colleagues and give your career a new meaning.

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Compliance Expert

Region: Belgium Kind of contract: Open-ended Work regime: Fulltime Location: BE - Louvain-la-Neuve

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