QAra Manager Healthcare

il y a 2 semaines

Gent, Belgique Robovision Temps plein

**Who are we?**

**Robovision** is a rapidly growing company at the forefront of AI development in Europe and beyond. We are active in several verticals, and for our healthcare vertical we’re developing state-of-the-art AI algorithms that will improve the outcomes and standard of care in hospitals. For this activity, we are looking for an exceptional **QARA Manager Healthcare**, who can manage quality assurance and regulatory affairs for our AI medical device software.

**What will you do?**

**Responsibilities**:

- ** Quality Management System (QMS)**:

- Ensure the QMS complies with ISO 13485 and other relevant standards.
- Maintain process documentation
- ** Regulatory Compliance**:

- Ensure adherence to regulatory standards (e.g., FDA, MDR).
- Prepare and manage regulatory submissions.
- Plan and manage internal and external audits.
- ** Risk Management**:

- Conduct risk assessments.
- Maintain risk management file in compliance with ISO 14971.
- ** Training and Awareness**:

- Conduct training on quality processes and regulatory requirements.
- Ensure team members are aware of quality and regulatory standards.
- ** Collaboration**:

- Work closely with the engineering team to ensure adherence to the QMS.
- Communicate with stakeholders about regulatory updates and compliance status.
- Review documentation against quality guidelines and procedures

**Who are you?**
- ** Technical Expertise**:

- Extensive experience in quality assurance and regulatory affairs.
- Strong understanding of medical device regulations and standards.
- Familiarity with risk management methodologies.
- **Regulatory Knowledge**:

- Proficiency in ISO 13485, IEC 62304, ISO 14971, IEC 62366, FDA QSR and FDA guidelines.
- **Soft Skills**:

- Excellent organizational and communication skills.
- Ability to train and mentor team members on regulatory practices.
- Proficiency in English.

**Nice-to-haves**:

- Experience with AI and software as a medical device (SaMD).

**What do we offer?**
- A dynamic high tech environment where initiative and strong hands-on mentality are valued
- A front seat in Belgium’s most exciting scale-up
- A competitive salary & benefits
- A young and open company culture where we focus on communication, partnership and team building activities.

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