Welcome to the application process - Regulatory Affairs / MDR

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Dear candidate,

We 'd love to get to know better and would like you to answer the following questions.
There are no right or wrong answers, these will only help us to understand if we can provide you with a fitting role :).

Since the role touches many different fields, you don’t have to bring all know-how already with you - we are welcoming passionate learners who want to develop themselves in this role, given they at least have solid knowledge of MDR.

Few words about us, we are a team of around 20 people dedicated to deliver the best service / product to our users. We believe that with the help of scientific partners, we can improve and help millions of people to take excellent care of their mental health.

We are looking very much forward to learning more about you!

Best regards,
The NeuroNation Team

Full Name *

Email *

Link to your CV (LinkedIn) *

In case you're applying at NeuroNation with the involvement of a recruitment company or "headhunter", please specify their name and company: *

No recruitment company or headhunter is involved in my application

Other:

In which country do you live? REQUIREMENT: Only countries in the EU are accepted. *

Are you located in the timezone CET +/- 2h? *

YES

Why are you applying at NeuroNation? *

Mainly to continue my career path and generally work in Regulatory (or similar)

Mainly to do something else than at my previous job

Mainly to have a secure job

Mainly to work in the digital field

Mainly to work in a growing company

Not sure

Other:

Please describe briefly what our product is in your view and what you think about it. *

If applicable, please mention briefly what parts and features of our product you have used or tested until now, what you think about them, and at what training session you are so far. *

If any, what digital medical devices / medical processes did you manage or worked on (Web URL or App Store link)? *

I didn't work on any digital medical product / medical service yet

Other:

Your academic background & professional qualification *

University degree or recognised degree in law, medicine, pharmacy, engineering or any other relevant scientific discipline

One year or more of professional experience in quality management or regulatory affairs

Four years or more of professional experience in quality management or regulatory affairs.

Training certificates on clinical evaluations

Training certificates on risk management (ISO 14971)

Training certificates on quality management (ISO 13485)

None of the above

Required

Which of these do you have SIGNIFICANT practical experience with?

Compliance with MDR

Compliance with MDD

Writing the Quality Management Documentation (ISO 13485)

Maintaining the Technical File

Writing the Usability Study Documentation (IEC 62366)

Writing the Risk Management Documentation (ISO 14971)

Writing a Clinical Evaluation Report

Conducting clinical evaluation and Post-Market Clinical Follow Ups (PMCF)

Managing projects and timelines for cross-disciplinary groups of people

Moderating meetings with groups of stakeholders

Defining tasks on Jira or other tools for implementation by developers

Delivering training to new team members

Compliance with DiGAV

Compliance with ISO 27001

Compliance with GDPR

Serving as Internal Auditor against QMS requirements

Achieving medical device certification with a notified body

Other:

If applicable: What are some of the non-fiction books you've read / listened to and educational courses you've completed in the last 2 years?

If applicable: What are some Health / Education apps you've used regularly over the course of multiple months?

How do you see your contribution to NeuroNation?

Is there anything, you would like to mention or would like to know about NeuroNation?

What are your possible starting dates and salary expectations? *

When would you have time for a regulatory challenge (a document with a set of questions to answer in writing)? Weekends also work. To respect your time, you'll only be asked to take the challenge after we've decided that your profile fully matches the job's needs. You'll receive a confirmation before. *

Thank you!

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