Regulatory Manager (IVD & SaMD)

hormona; Greater London; On-site; GBP 50,000 - 70,000; Full time

Job summary

A women’s health technology company based in the United Kingdom is seeking an experienced Regulatory Manager for a 12-month maternity leave cover. The role involves ensuring compliance with EU regulations and improving the company’s quality management system. The successful candidate will serve as the Management Representative and oversee various compliance matters, thereby contributing significantly to regulatory strategies as the company scales globally. The position promises an exciting opportunity to make a real impact in a fast-growing sector.

Qualifications

• Experience with EU MDR 2017 / 745 and/or EU IVDR 2017 / 746 compliance.
• Proven experience in quality management systems (ISO 13485).
• Strong understanding of regulatory submissions and audits.

Responsibilities

• Serve as Management Representative and PRRC, ensuring compliance.
• Maintain and improve ISO 13485-compliant QMS.

Job description

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

• Serve as Hormona’s Management Representative and PRRC, ensuring compliance with EU MDR 2017 / 745, and / or EU IVDR 2017 / 746.
• Maintain and continuously improve Hormona’s ISO 13485-compliant QMS, including document control, internal audits, CAPA, management reviews, and quality records, and supplier management.

Over...