Cofounder – DTx (Regulatory & Market Access, SaMD / DiGA / NHS)

Job title:

Cofounder – DTx (Regulatory & Market Access, SaMD / DiGA / NHS)

Company

Zenna

Job description

Zenna is a DTx IP spin-out from a neuroscience research firm. We harness brainwave therapy through sound modulation to treat migraine and headache conditions. Our solution provides patients with the world’s first non-invasive and convenient option to manage their pain using only a regular headphone and mobile phone, anywhere, anytime. With clinical validation at our core, we have validated the solution through rigorous clinical trials involving over 5,000 patients in collaboration with public hospitals.We’re looking for a co-founder with a strong background in digital health regulation or commercialization in Europe—especially with experience navigating DiGA (Germany) or NHS pathways (UK). You’ll play a central role in bringing a category-defining therapy to market.We’re open to hearing from you even if you meet ~60% of the requirements—mindset and mission-fit matter most.TasksAs our Cofounder – Regulatory & Commercial Lead, you’ll spearhead Zenna’s entry into European healthcare systems, defining the regulatory strategy (as a SaMD) and leading market access and commercialization efforts through DiGA, NHS, and other digital formularies.Your leadership will shape the path from clinical validation to real-world adoption, ensuring our non-invasive DTx therapy reaches patients who need it.

• Regulatory Leadership: Drive Zenna’s regulatory strategy as a SaMD, including CE marking, UKCA, MHRA approvals, and the DiGA Fast-Track in Germany.
• Market Access & Commercialization: Lead our entry into European healthcare systems like DiGA and NHS, securing reimbursement and scaling adoption.
• Clinical Validation: Develop clinical trial partnership with universities labs, facilitate trial design and evidence generation to meet both regulatory and payer standards.
• Cross-Functional Collaboration: Work with neuroscience, product, and engineering teams to align product development with compliance and commercial goals.
• Partnerships & Business Development : Build relationships with payers, health systems, clinical trial partner, and key stakeholders to unlock growth opportunities.

RequirementsWhat We’re Looking For:

• Experience with regulatory approval processes for SaMD / medical devices, especially CE-marking, UKCA, MDR, and engagement with BfArM or MHRA.
• Track record of bringing medical or digital health products to market in Europe, ideally through DiGA (Germany) or NHS Innovation/Procurement pathways (UK).
• Deep understanding of reimbursement, digital formularies, and evidence requirements for digital therapeutics or medical software in public health systems.
• Experience building go-to-market strategies or pricing/reimbursement models for health tech.
• Bonus: MD, PhD, or clinical background (neuroscience, neurology, psychiatry, or pain management), but not required.

Ideal BackgroundYou might be a fit if you’ve:

• Led regulatory or market access strategy for a digital health or medical device startup.
• Worked with BfArM or MHRA, or helped navigate the DiGA Fast-Track process.
• Scaled commercial operations for a SaMD or DTx product in Europe.
• Acted as the bridge between product, clinical, and commercial teams in a healthcare startup.

Nice-to-have

• Experience in medical product development, clinical trials, health tech or digital therapeutics.
• Experience as a key leader or co-founder in a fast-growing startup in health tech or digital therapeutics.
• Prior experience in building and scaling digital health solutions.

Startup Mindset

• Flexible, adaptable, and driven by impact.
• Energized by ambiguity, and excited to build from the ground up.

BenefitsWhy Zenna?

• Mission-Driven: Help revolutionize mental health care with innovative solutions that make a real difference in people’s lives.
• Co-founder Equity – Own a share of the company from the start
• £2.2k monthly stipend – Cover initial costs as we build
• Office space in Euston, London – Work alongside other deep-tech founders and ecosystem players at Zinc VC.
• Zinc VC Network & Support – Access to coaching, investor network, mentors, and business support.
• Salary post-investment – Competitive pay after funding

If you’re a visionary health tech leader with experience in regulation or commercialization, and you’re excited to co-build a breakthrough in digital therapeutics—we want to hear from you!ZennaAt Zenna, we are transforming migraine management with our proprietary algorithm that generates personalized therapeutic soundtracks based on users’ real-time health data. Our technology tracks and responds to migraine outbreaks automatically and allows users to adjust pain locations, providing precise sound therapy in real time. With just a smartphone and headphones, users can effectively manage migraines as well as conditions like depression , anxiety, and insomnia —anytime, anywhere. In collaboration with public hospitals, we have tested our solution on over 5,000 patients, demonstrating an 85% effectiveness rate. Zenna offers a non-invasive, drug-free approach that empowers individuals to take control of their mental health effortlessly.

Expected salary

Location

London

Job date

Fri, 28 Mar 2025 23:01:28 GMT

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