Operational Product Compliance Expert

il y a 1 jour


LouvainlaNeuve, Belgique IBA Temps plein

**Requisition ID**:2911**Location**:Louvain-la-Neuve, BE**Work regime**:Full-Time**Kind of contract**:Open Ended Contract**Mission**
IBA Technologies (an entity of IBA) is willing to reinforce its practice and processes related to its existing and future products, towards more efficiency and compliance reinforcement. As a consequence, we are now looking for a pragmatic technical expert with the drive to make things happen.
Our **Operational Product Compliance Expert** position is located in Louvain-la-Neuve within the Quality department of the IBA Technologies entity and will require close collaboration with all IBA Business Units.

**Challenges we trust you with**
- Support R&D experts and product management teams of IBA Radiopharma Solutions (RPS) and IBA Industrial Solutions (Indus) with their product compliance:

- Supporting the development of the product compliance roadmap
- Analysing technical standards applicability, performing gap assessment and impact analysis on RPS and Indus products
- Finding the right balance between traceability to standards and testing methodology and overall cost to the company
- Supporting implementation and evolution of digital tools to achieve this purpose
- Identifying external partners such as testing labs and be their main contact point
- Lead the Product Compliance Steering Committee for IBA Technologies
- Interface and coordinate activities with the IBA Clinical entity through:

- Representing IBA Technologies in joint product compliance efforts with IBA Clinical
- Driving high level alignment, convergences and synergies of compliance roadmaps
- Follow-up compliance proactive and corrective (post-audit) actions

**What we value**
You have:

- Master degree in a technical field (science, engineering )
- 5+ year experience in project management in a regulated environment
- Experience in achieving product and process compliance, e.g. using technical standards as a support
- Experience in specifying and setting up modern traceability tools (e.g. Siemens Polarion)
- Communication and plan follow-up in JIRA and Confluence is an asset
- Specific knowledge in Electromechanical Systems/Machinery is another asset, e.g. in the domain of electromagnetic compatibility, electrical safety
- Excellent communication skills and can adapt your message to your audience
- French and English are required

**And you also are**:

- Able to organize your work autonomously and take initiatives
- Curious, you care for other’s needs and are willing to anticipate these
- Problem-solving oriented
- A team player having the passion to listen, understand, communicate and positively impact the business


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