Head of QARA

Sumár práce
Plný úväzok
Paris
Príležitostná práca na diaľku
Plat: Neuvedené
Zručnosti & odborná znalosť
Komunikačné zručnosti
Riadenie kvality
Dodržiavanie právnych predpisov
Spolupráca a tímová práca

Perifit
Perifit

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Our Mission

⭐️ Perifit is a profitable and fast-growing femtech startup based in Paris, France. Turnover was multiplied by 100 in 5 years !

Our goal is to assist women worldwide with the most challenging moments in their lives - moments that are heavily under-addressed - and do benefit from fun and effective self-care solutions.

Our first product, the Perifit (a connected probe and its mobile games), launched in 2018, has become the #1 connected solution for pelvic floor rehabilitation. As of now, it has helped a whooping 500.000 women cure themselves and is the best-ranked app in its category.

We now develop innovative pelvic floor trainers and breast pumps that use the most recent technologies to help women improve their lives. Our mission is to empower women to take control of their health and improve their overall well-being.

Our team grew from 2 co-founders to approximately 40+ employees in three years (2020 to 2025), and we operate in a truly global environment, with customers and partners around the world.

At Perifit, we stand for equality, inclusivity, benevolence and wellbeing for both our clients and our employees.

Joining Perifit means being part of a dynamic, mission-driven team that is making a real difference in women’s lives, and having the opportunity to contribute to a growing and innovative startup in the Femtech industry !

We’re very proud of our values ! FREEDOM – FEMINISM – STARTUP MINDSET – REAL IMPACT – NO EGO

Why we need you 🚀

We have grown fast, iterating quickly on our products to deliver what our customers need and have become one of the top femtech companies in the world. As we expand our product portfolio, enter new markets, and continuously improve our solutions, we need to strengthen our Quality and Regulatory processes. We need to ensure compliance of the product while remaining easy to manufacture, high-quality, and customer-friendly. We are looking for a solid and pragmatic leader to manage multiple products across diverse markets efficiently.

As our Head of QARA, you will be the strategic and operational leader ensuring regulatory compliance, product quality, and smooth market access for our pelvic floor trainers and breast pumps in Europe (Class I) and the US (Class II under FDA 510(k)). Your mission will be to drive regulatory submissions, ensure ISO 13485 compliance by implementing quality processes that balance efficiency and compliance. With your expertise, we can continue delivering trusted, high-quality solutions that positively impact women’s health worldwide. 💪🌍

What you will be doing 🎯

You will lead regulatory and quality assurance efforts to ensure Perifit’s products comply with international standards while maintaining customer satisfaction.

You will improve production quality and reduce customer returns through post-market surveillance and CAPA processes. Maintaining and refining our ISO 13485-certified QMS, you will ensure regulatory and quality processes remain efficient and adaptable.

You will develop and execute regulatory strategies for product launches, ensuring FDA Class II, CE marking (Class I), and ISO 13485 compliance.

As the leader of the QARA team, you will foster a compliance culture while avoid unnecessary bureaucracy. You will collaborate with R&D, Manufacturing, and Supply Chain teams to integrate compliance and quality into product development and production.


Preferované skúsenosti

What hard skills we need to see 🛠️

Educational Background: An engineering degree in Engineering or Regulatory affairs. Relevant Experience: 7+ years of experience in Regulatory Affairs & Quality Assurance for medical devices, ideally in electronic medical devices (Class I preferred). At least 3 years with a management position.

Experience with FDA : tracked record of participation in successful 510k submissions

What kind of person we are looking for 👤

Mindset: Pragmatic and process-driven, with a strong ability to prioritise, stay organised, and follow through on commitments. You focus on efficiency and practical solutions without unnecessary complexity.

You are a feminist: You believe in the right of every woman to have access to fun and effective health solutions. You are comfortable talking about women’s health issues, are not intimidated by the topics of pelvic floor health, the vagina, childbirth and female intimacy in general, and curious to learn more.

Team Collaboration: A track record of working effectively with cross-functional teams in a dynamic environment.

Language Proficiency: Fluent in English, with strong technical writing skills and clear communication abilities.

You will shine if ✨

Experience in Mass Production: You have worked with companies manufacturing products at scale and understand the challenges of ensuring quality and compliance in high-volume production.

Connected Device Experience: You have hands-on experience working with connected devices and understand the specific regulatory and technical challenges they present.

Global Regulatory Exposure: You are familiar with international regulatory frameworks such as TGA Australia, Health Canada, or other regional standards, enabling smoother market access.

Mandarin Proficiency: A plus for collaborating effectively with manufacturing partners and suppliers in China.

Why this is an offer you can’t refuse 🎉

If you work with us, you’ll have a direct, meaningful impact on the lives of hundreds of thousands of women—and their children. That’s a lot of people ! You’ll be part of a challenging, fast-paced environment where your mission is clear: create the absolute best for our customers.

You will be responsible on your perimeter. No one in our company will know more about our V&V processes than you.

See also our advantages below !

🏥 Comprehensive Health Coverage: Excellent mutual health insurance (Alan) 100% financed by the company.

🍱 Meal Benefits: Swile “restaurant tickets,” 60% covered by the company.

🏋️‍♀️ Wellness Support: Free subscription to Classpass to stay healthy and energized.

🏢 Flexible and Friendly Work Environment: Spacious offices in the heart of Paris with a welcoming atmosphere.

Keywords: Head of QARA, Regulatory Affairs, Quality Assurance, Medical Devices, ISO 13485, FDA 510(k), Risk Management, Femtech.


Náborový proces

  • Cognitive test

  • Screening call

  • Use Case

  • Call CTO

  • Call CEO

  • Reference Check

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