Regulatory Affairs Associate

**Description**:
The Regulatory Affairs Assistant provides support for any regulatory questions related to Belgian Volition products. By bringing their expertise, they will also support product regulatory compliance during product development and post marketing activities.

**Key Responsibilities**:

- Support the QA/RA team in active regulatory surveillance on the standards and regulations applicable to company activities.
- Identify, analyze and communicate regulatory changes with review of their impact for the company.
- Provide support and technical guidance on any regulatory issues to all departments of the company.
- Support Product Development team in Product Development IVDR process management and compile related documentation.
- Help maintaining product technical documentation up-to-date.
Participate in Post-Marketing Surveillance activities.
- Support QA team in change control management and product update.
- Participate in risk management related to products.
- Manage CAPAs and nonconformities, when applicable.

**Skills, Knowledge and Expertise**:

- Master degree in a scientific field;
- Previous experience in Regulatory Affairs (or alternatively Quality assurance) in the IVD industry is an asset;
- Excellent knowledge of applicable IVD regulation:

- IVDR (Regulation EU 2017/746);
- ISO 13485;
- ISO14971;
- REACH;
- FDA medical;
- MEDDEV;
- MDSAP;
- Other regulatory knowledge is welcome
- Understanding of IVD product development process, quality systems, and clinical trials;
- Good computer skills.

**Benefits**:

- Meal Vouchers
- Group insurance;
- DKV (inpatient and outpatient);
- DKV Hospitalization (offered for the family);
- End of Year Bonus;
- Eco-cheques;
- Double Holiday Allowance;
- Annual CCT90 Bonus;
- Annual Personal Targets;
- Annual Corporate Objectives;
- Flexible Teleworking.

**About Volition**:
Brighter tomorrow

We are dedicated to revolutionizing the diagnosis and monitoring of life-altering diseases by advancing the science of epigenetics.

Our mission is to save lives and improve outcomes for millions of people and animals worldwide.

Imagine a world where diseases like cancer and sepsis can be diagnosed early and monitored easily using routine blood tests. That’s the world we’re trying to build by developing our innovative family of simple, easy to use, cost-effective Nu.Q® tests.

Our patented Nucleosomics technology uses chromosomal structures called nucleosomes as biomarkers in cancer and other diseases. All the tests in our portfolio detect various characteristic changes in nucleosomes that occur from the earliest stages of disease, enabling early detection and potentially a better way to monitor disease progression and the patient’s response to treatment.

Volition has four pillars of focus: Nu.Q®, Nu.Q® NETs, Nu.Q® Capture and Nu.Q® Vet.

We are headquartered in Austin, Texas, with locations in Belgium, California, Singapore and the UK. We are listed on the New York Stock Exchange (NYSE AMERICAN) as VolitionRX Limited (VNRX).