Regulatory Compliance Manager

**Regulatory Compliance Manager**

Are you passionate about technology, regulatory strategy, and making a real impact in global healthcare? At QMENTA, we are transforming neuroimaging with AI and cloud-based solutions. We’re looking for a Regulatory Compliance Manager to lead our regulatory strategy and ensure compliance across our advanced healthcare imaging and data management platforms.

**Who we are**

**QMENTA** is a cutting-edge software company providing a comprehensive platform for managing, analyzing, and interpreting medical images in research and clinical trials. Our technology enables faster diagnosis of neurological diseases like Parkinson’s, Alzheimer’s, and multiple sclerosis, and accelerates clinical trials through powerful AI-driven tools.

Our scalable cloud-based infrastructure integrates AI-powered imaging biomarkers and automated workflows to enhance medical imaging accuracy and collaboration across global research teams. If you're excited to drive innovation in healthcare and work with mission-driven colleagues, **QMENTA**is the place for you

**What You'll Do**

Regulatory Affairs Leadership
- Define and lead regulatory strategy for our cloud-based healthcare imaging platforms.
- Act as the main point of contact with regulatory bodies and manage all related communications.
- Develop regulatory roadmaps aligned with product timelines and go-to-market strategies.
- Stay on top of changes in the global regulatory landscape for healthtech and digital health.

Compliance Management
- Ensure compliance with key standards: GDPR, HIPAA, FDA 21 CFR Part 11, ISO 13485, IEC 62304, among others.
- Lead gap assessments for new markets and evolving requirements.
- Oversee privacy, data protection, and clinical data handling compliance across platforms.
- Manage incident responses and interactions with regulatory authorities.

QMS Integration
- Collaborate with our Quality team to align regulatory needs with QMS processes.
- Review and approve quality documentation with a regulatory lens.
- Support internal and external audits and lead regulatory training initiatives.

Cross-functional Collaboration
- Partner with Engineering to ensure regulatory-compliant product development.
- Support Business Development with regulatory insights into market strategy.
- Advise senior leadership on regulatory risks and opportunities.
- Work with Legal and IP teams on regulatory issues impacting commercialization.

**What We’re Looking For**

Experience & Knowledge
- 5+ years in regulatory affairs or compliance in healthcare IT, medtech, or life sciences.
- Strong knowledge of healthcare data regulations (GDPR, HIPAA, GCP, etc.).
- Familiarity with ISO 13485, IEC 62304, and cloud-based compliance frameworks.
- Experience navigating international regulations and cross-border data requirements.
- Understanding of cybersecurity and data protection frameworks in healthcare.
- Bonus: Knowledge of AI/ML regulations (e.g. EU AI Act, FDA AI/ML guidance) or medical device pathways (CE mark, 510(k)).

Skills & Traits
- Excellent written and spoken English communication skills.
- Strategic thinker with hands-on execution skills.
- Strong project management and organizational capabilities.
- Comfortable working in dynamic, fast-paced environments.
- Culturally aware and collaborative with international teams.

What We Offer
- 23 paid vacation days per year, plus local public holidays.
- Flexible compensation plan - including meal vouchers and private health insurance.
- Hybrid work model: 2 days per week at the office, with flexible schedule.
- Modern office in Barcelona, well-connected by public transport.
- Inclusive and diverse culture where your voice matters and you can make a difference.

**Ready to make a real-world impact?

**We Are an Equal Opportunity Employer**

**QMENTA**is proud to be an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. We welcome applicants of any race, color, religion (or no religion), national origin, gender, gender identity, sexual orientation, age, marital or civil status, pregnancy, disability, or any other legally protected characteristic. At **QMENTA**, we believe that a diverse team makes better decisions and drives innovation.