Regulatory Affairs Specialist

About MammoCheck

MammoCheck Ltd is a Cyprus-based medical technology company and a Frederick University spin-out. We are developing an AI-powered Software as a Medical Device (SaMD) for adjunctive breast cancer screening. Our solution pairs consumer thermal imaging hardware with a proprietary deep learning model, delivered through a smartphone application, and is designed to support rather than replace clinical judgement. The product is positioned strictly as adjunctive and investigational while we advance toward FDA 510(k) clearance and CE marking under the EU Medical Device Regulation (EU MDR). We are now building the in-house regulatory and quality capability that will carry the product through clinical validation, regulatory submission, and market entry.

Role overview

As Regulatory Affairs Specialist, you will be responsible for implementing MammoCheck's regulatory system and documentation as we advance toward FDA 510(k) clearance and CE marking under EU MDR. This is genuine implementation ownership, not an assistant role. You will build and maintain the technical documentation, run the submission workstreams, and keep the company audit-ready, while receiving structured guidance and training from our external regulatory consultants and hands-on support from the management team and the technical team. It is an exceptional opportunity for a motivated professional to implement a full FDA and EU regulatory pathway from an early stage, with expert mentorship built in.

What you will implement

• Implement and maintain the regulatory documentation system, including the technical file, the design history file, and labelling, with training and templates provided by our external consultants.
• Build and run the regulatory submission workstreams for FDA 510(k) and EU MDR CE marking, executing the strategy set with our consultants and management.
• Implement the FDA Pre-Submission (Q-Sub) package preparation and maintain all correspondence records with authorities and Notified Bodies.
• Set up and own the regulatory trackers, timelines, and standards library, and monitor changes to relevant requirements, including AI and machine learning guidance and the EU AI Act.
• Implement the claims review process, ensuring product, app, and marketing materials remain consistent with the adjunctive, clinician-reviewed, and investigational positioning.
• Implement and maintain the regulatory documentation supporting the clinical study, working with the clinical team.
• Work day to day with the software, AI, and clinical teams, who will provide the technical inputs and support you need.

Guidance, training, and support

You will not be doing this alone. Strategy and specialist judgement are provided by our external consultants, who will train you on the frameworks, review your work, and remain available throughout. The management team provides direction and removes blockers, and the technical team supplies the engineering inputs and tooling you need. Your job is to implement, own the day-to-day system, and grow into the expert in the room.

Required qualifications

• A degree in life sciences, biomedical engineering, pharmacy, regulatory science, or a related field.
• One to three years of experience in regulatory affairs, quality, or a documentation-heavy role, ideally in medical devices or another regulated sector.
• Familiarity with, or a strong willingness to learn, the FDA 510(k) pathway and the EU Medical Device Regulation. Full training will be provided by our external consultants.
• Awareness of core standards such as ISO 13485, ISO 14971, and IEC 62304.
• A self-starter mindset. You will implement the system hands-on, with guidance rather than day-to-day supervision.
• Excellent written and spoken English, with strong attention to detail and technical writing ability.

Preferred qualifications

• Exposure to Software as a Medical Device or digital health.
• Progress toward RAPS certification.
• Familiarity with AI and machine learning device considerations.
• Knowledge of Greek.

What we offer

• A competitive salary.
• Flexible and hybrid working arrangements.
• Structured guidance and training from our external regulatory and quality consultants, FDA and EU MDR advisors.
• Direct support from the management team and the technical team, so you are never implementing alone.
• Support for professional development and certification, including RAPS and ISO 13485 training.
• Real implementation ownership from day one, with a clear path to grow into a senior regulatory role as the company scales.

How to apply

To apply, please send your CV and a short cover letter to [email protected] with the role title in the subject line, or apply directly using the form below. Applications are reviewed on a rolling basis.