Senior Quality & Regulatory Affairs Manager

Permanent employee, Full or part-time · Berlin, Remote

⭐️ ABOUT THE COMPANY

At inne, we have seen firsthand how women’s need for female health education and accurate fertility insights have been underserved. So we made it our obsession to use the best of science, tech, and design to bring actionable scientific insights into female health.

We are an interdisciplinary team and have developed our first innovative biotech product which enables women to analyse fertility hormones in their saliva.
With this insight, we want to follow our mission to help women tune into their bodies and make informed decisions about their fertility, sexuality, and overall female health!
We are pushing the boundaries of science, technology, and design and are guided by our values. In 2022 alone, we will be adding new hormone detection in our product, opening up our product to cater to women of different ages, and providing even more female health insights.

We breathe and live our values of compassion, continuous learning and make an impact in the way we relate to our customers, we develop our product, we support each other in being our best selves, and navigate the uncertainties of working in an under-looked area.

If you want to be part of creating a disruptive wave in female health, you have come to the right place!

⚡️ YOUR MISSION

As a Senior Quality and Regulatory Affairs Manager at inne, your mission will be to:

Ensure that our processes and products meet all necessary quality and regulatory requirements before they reach the users
Implement and maintain a Quality Management System (QMS) that complies with ISO 13485, ISO 14971, IVDR and FDA 510(k)
Generate and maintain technical files, including documentation for clinical studies
Communicate with Notified Body and other responsible authorities

☀️ ABOUT YOU

You definitely bring:

Experience managing QM systems in accordance with ISO 13485, ISO 14971 and FDA
At least five years of experience with QMS and regulatory affairs for medical devices, preferably with in-vitro diagnostic devices
Knowledge of in-vitro diagnostic medical devices regulation IVDR and CFR
Experience conducting internal as well as supplier audit
Thoroughness and keen attention to detail
Continuous improvement and problem-solving mentality
Excellent communication and active listening skills
Fluent in English and at least intermediate German communication skills (level B2 or above)

❤️ WORKING WITH US

Being part of our team means joining an expedition.
We uncover, learn, innovate, and do it with compassion at the heart of it all. Our goal is to shed light on the connection between hormones and female health and create new resources for women to better understand themselves.
If you are looking for a job that is more than “just a job” and you are hungry to bring your skills to the amazing mix of talent behind inne, then this is the right place for you. Join us to push the boundaries of female health!

✨ OUR OFFER AND BENEFITS

Competitive salary
Possibility of participating in the company's virtual stock options programme after the end of the probation period
Monthly coaching
For Berlin-based team: hybrid working conditions, with two days of mandatory in-office presence in our beautiful, central and dog-friendly location in Berlin Kreuzberg. For remote team: work is remote but requires travel to the Berlin office once per month.
An opportunity to work in a fast-growing startup that has developed its own innovative product to make a true difference in women’s lives
A fun and friendly work environment with a diverse group of talented and motivated colleagues

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About us

We exist to help women make informed decisions about their fertility and overall female health by making products that fit seamlessly into their lives.

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We are looking forward to hearing from you!

Thank you for your interest in working with us at inne. Please fill out the following short form. Should you have difficulties uploading your data, please send an email to team@inne.io.