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.

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.

• Screening call (30min)

• Test (2 hours)

• Interview with manager (1 hour 30 min)

• Interview with CEO (1 hour)