CERTIFICATION SPECIALIST IN MEDICAL DEVICES

Job Summary (0.8 – 1.0 FTE):

Do you have an interest in being at the forefront of innovation for patient care? Do you have an affinity for medical technology? Do you want to be part of the next generation of neurotechnological products to diagnose sensory pathways? Then you might be MindAffect’s new certification specialist in medical devices.

What you can expect from this role:

As our Certification specialist you will take ownership of the regulatory strategy and its implementation at MindAffect. This is a critical role to the company's future. For this position, knowledge on the European Medical Device Regulation (MDR) and US FDA certification Process for Class 2a medical devices is required.

Your main task will include:

Develop and execute the global regulatory strategy of MindAffect working closely with the senior management team
Lead the implementation of our medical device certification process and oversee the continuous compliance for medical software in the EU (MDR) with the senior management and a professional certification advisory firm
Develop and maintain internal procedures to ensure compliance to MDR as well other medical device regulations and standards
Gather, structure, and formalize relevant information in order to fulfill regulatory requirements
Create, implement, and document processes together with internal cross-functional teams like Engineering,
Product development, R&D, and Management team
Promote awareness of the MDR throughout the organization through regular training/briefing sessions
Monitor and communicate progress of the MDR project to ensure compliance with internal quality objectives
Guide product reviewers and other clinical experts in the assessment of the clinical evaluation

Where you will work:

The job can be mostly performed remotely. However, it is required that we meet at the office once a week. The office is located in Ede, Netherlands. Our growing team currently consists of 9 international R&D engineers and software specialists who are highly enthusiastic and committed professionals.

Qualifications and Skills:

Bachelor/Masters Degree (HBO or University) in a clinical or technical field
Experience with Medical Certification Process
Good organizational and people management skills
You work in a structured manner and pay attention to quality and details
You are a strong communicator, both orally and in writing
Extensive knowledge of Word, Excel, and Powerpoint
Excellent command of English and good command of the Dutch language
Knowledge in basic neuroscience and/or brain imaging and/or the hearing/vision medical field is a bonus

What we offer:

Competitive salary and benefits
Good work-life balance is important to us
A chance to be a part of bringing exciting technology out of the lab and into the real world for the benefit of over 2 billion people worldwide
Working in an inspiring start-up mentality team with ambitious and driven professionals in the field
Opportunity to expand your knowledge and learn skills that interest you
Travel allowance

More information:

For more questions on the position please feel free to contact info@mindaffect.nl.

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