Head of QARA
Head of QARA
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Job Description
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 highquality and customerfriendly. 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 highquality 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 postmarket surveillance and CAPA processes. Maintaining and refining our ISO 13485certified 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.
Required Experience:
Director
Employment Type
Full-Time
