QAra Manager Healthcare
il y a 2 semaines
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 handson mentality are valued
- A front seat in Belgium's most exciting scaleup
- A competitive salary & benefits
- A young and open company culture where we focus on communication, partnership and team building activities.
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