Regulatory Affairs Associate

il y a 2 semaines

LouvainlaNeuve, Belgique IBA Temps plein

**Requisition ID**:1953**Location**:Louvain-la-Neuve, BE**Shift**:Full-Time**Kind of contract**:Open Ended Contract**Mission**
You will report to the Regulatory Affairs Director. He/she will perform and manage regulatory activities within a highly regulated, fast-paced industry to ensure that Company objectives are achieved in compliance with regulatory requirements. He/she will be in charge for managing all RA aspects associated with the development of new product projects and for communication with competent authorities according to the geographical area responsibilities.

**Challenges we trust you with**
- Manage simple to moderate complexity regulatory projects
- Identify laws, regulations, standards and guidance applicable to the organization in the target markets as defined by the management and according to the product specificities
- Ensure regulatory compliance with applicable standards, directives and regulations
- Identify deliverable documents required for market registration and conduct pre-survey reviews of these deliverables
- Work proactively and closely with cross-functional teams on new product/feature launches according target market requirements. Provide guidance to the same
- Assist RA management with activities related to regulatory inspections. Fulfill requests from other departments related to regulatory information and documentation

**What we value**

**You have**:

- A Scientific degree (Pharma, Electromechanics, Chemistry etc.) with a keen interest in understanding the technical aspects of the product
- 0-3 years of industrial experience
- Good problem-solving skills, analytical capacity, and the ability to understand and follow instructions independently.
- A proactive approach, capable of seeking information autonomously and ensuring timely and high-quality document deliverables.
- Proficiency in English and secondary in French
- Basic knowledge of European and/or US regulation on Medical Devices is a plus

**Life at IBA**

IBA Group

IBA is offering a broad and amazing diversity of careers. For our business units to perform at their best, they can rely on various shared services that give the appropriate support to each activities so that they can run their business smoothly. Finance, legal, corporate communication, human resources play together a key role in the company growth.

**IBA: Protect, Enhance and Save Lives**

IBA is driven by a mission to Protect, Enhance and Save Lives. IBA’s innovative mindset, dedication to technological and scientific progress and long-standing open relationships with customers and partners make IBA a unique scientific company.

**A committed company**

IBA believes in a business model that creates shared and long-term value for all its stakeholders:
IBA increases market share and return for its shareholders, improves quality of life for its customers, patients and employees, and contributes to the well-being of the society. All while maintaining and restoring the planet’s health. IBA has integrated this stakeholder approach into its company bylaws.

This vision is operationalized since 2021 by the B-Corp certification, a holistic tool to assess, benchmark and ultimately improve its sustainability journey.

Learn more about IBA and its technologies, download our new corporate brochure or visit our corporate website.

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