Job Description
About Us
Hormona is a data-driven women’s health company on a mission to revolutionize female health. Our award-winning app is the first comprehensive, personalized hormone-tracking platform that helps women understand and optimize their hormonal well-being. With features like cycle tracking, symptom logging, personalized insights, and expert-backed recommendations, we’re leading the way in “Hormone Health.”
The Role
We’re looking for an experienced Regulatory Manager to join us on a maternity leave cover contract (12 months). This is a pivotal role ensuring compliance across our Software as a Medical Device (SaMD), In Vitro Diagnostic (IVD), and wellness products as we continue to scale globally. The successful candidate will also be formally appointed as Management Representative and Person Responsible for Regulatory Compliance (PRRC) under EU IVDR, representing Hormona in all quality, regulatory, and compliance matters.
Responsibilities
1. Serve as Hormona’s Management Representative and PRRC, ensuring compliance with EU MDR 2017/745, and/or EU IVDR 2017/746.
2. Maintain and continuously improve Hormona’s ISO 13485-compliant QMS, including document control, internal audits, CAPA, management reviews, and quality records, and supplier management.
3. Over...