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1 433 postes de

Biotechnologie à France

Head of Regulatory Affairs

Perifit

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Sur place
EUR 70 000 - 90 000
Il y a 30+ jours
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Technicien / Technicienne de laboratoires d'analyses médicales (H/F)

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Metz
Sur place
EUR 20 000 - 40 000
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Senior Scientist , Analytical Development and Service (all genders)

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EUR 70 000 - 90 000
Il y a 30+ jours

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EUR 80 000 - 100 000
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EUR 80 000 - 100 000
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EUR 60 000 - 80 000
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EUR 80 000 - 100 000
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EUR 40 000 - 60 000
Il y a 30+ jours

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Il y a 30+ jours

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Head of Regulatory Affairs
Perifit
Paris
Sur place
EUR 70 000 - 90 000
Plein temps
Il y a 30+ jours

Résumé du poste

A leading femtech startup based in Paris is seeking a Head of QARA to ensure regulatory compliance and product quality for innovative pelvic floor trainers and breast pumps. The ideal candidate will lead efforts to improve production quality, execute regulatory strategies, and foster a compliance culture while collaborating across teams. Competitive salary and a chance to contribute to an impactful mission in women's health.

Qualifications

  • Extensive experience ensuring regulatory compliance in healthcare products.
  • Proven track record in managing product quality.
  • Experience with ISO 13485 and FDA regulations.

Responsabilités

  • Lead regulatory and quality assurance efforts.
  • Improve production quality and reduce customer returns.
  • Develop regulatory strategies for product launches.
  • Collaborate with cross-functional teams to integrate compliance.

Connaissances

Proofreading
Adobe Acrobat
FDA Regulations
Manufacturing & Controls
Biotechnology
Clinical Trials
Research & Development
GLP
cGMP
Product Development
Chemistry
Writing Skills
Description du poste
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 womens 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 womens health worldwide.

What you will be doing

You will lead regulatory and quality assurance efforts to ensure Perifits 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.

Key Skills
  • Proofreading
  • Adobe Acrobat
  • FDA Regulations
  • Manufacturing & Controls
  • Biotechnology
  • Clinical Trials
  • Research & Development
  • GLP
  • cGMP
  • Product Development
  • Chemistry
  • Writing Skills

Required Experience : Director

Employment Type

Employment Type : Full‑Time

Experience

Experience : years

Vacancy

Vacancy : 1

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* Le salaire de référence se base sur les salaires cibles des leaders du marché dans leurs secteurs correspondants. Il vise à servir de guide pour aider les membres Premium à évaluer les postes vacants et contribuer aux négociations salariales. Le salaire de référence n’est pas fourni directement par l’entreprise et peut pourrait être beaucoup plus élevé ou plus bas.

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