Regulatory Affairs Lead

Startupvalleys; Zürich; On-site; CHF 120,000 - 180,000; Part time

Benefits offered by this job

Part-time option

Consultant-like arrangement

Equity discussions

Job summary

EVIIVE is seeking a motivated Regulatory Affairs Lead to guide our diagnostic platform through early clinical and in-house IVD regulatory pathways. You will lead documentation for Swiss IvDO compliance, support QMS implementation, and prepare submissions for IVDR and FDA pathways.

You will define strategy across CH/EU/US, draft essential regulatory docs, and interact with Swissmedic and Notified Bodies while collaborating with clinical partners to accelerate real-world impact.

Qualifications

• 3+ years experience in regulatory affairs (IVDs or diagnostics)
• Familiarity with IVDR, Swiss IvDO, and LDT regulations
• Independent working style and excellent written communication
• Bonus: Experience in early-stage diagnostics or health-tech startups

Responsibilities

• Define and manage regulatory strategy across key jurisdictions (CH/EU/US)
• Draft and maintain regulatory documentation (e.g., Declaration of Compliance, performance evaluation reports)
• Support ISO 13485 alignment and interact with Swissmedic, Notified Bodies, and clinical partners

Job description

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EVIIVE AG is looking for a motivated and detail-oriented Regulatory Affairs Lead to guide our diagnostic platform through early clinical and in-house IVD regulatory pathways. You will lead documentation for Swiss IvDO compliance, support QMS implementation, and prepare submissions for IVDR and FDA pathways.

What you'll do

Define and manage regulatory strategy across key jurisdictions (CH/EU/US)

Draft and maintain regulatory documentation (e.g., Declaration of Compliance, performance evaluation reports)

Support ISO 13485 alignment and interact with Swissmedic, Notified Bodies, and clinical partners

You bring

3+ years experience in regulatory affairs (IVDs or diagnostics)

Familiarity with IVDR, Swiss IvDO, and LDT regulations

Independent working style and excellent written communication

Bonus: Experience in early-stage diagnostics or health-tech startups

What we offer

Flexibility to work part-time or as a consultant, on your schedule

Direct influence on the regulatory path of a breakthrough diagnostic platform

Close collaboration with founders, advisors, and global clinical partners

A lean, mission-driven environment where your work accelerates real-world impact

Equity discussions available for long-term contributors

Work at EVIIVE

In the era of precision medicine, diagnostics is no longer just a tool for detection—it’s a gateway to better decisions, faster interventions, and more lives saved. At EVIIVE, we are reengineering how disease is identified and treated, starting at the nanoscale with single extracellular vesicles (EVs) and translating those insights into actionable clinical tools.

Through the fusion of immunobiology, machine learning, and real-time liquid biopsy, we’re building a platform that gives clinicians clarity—and gives patients a second chance. Whether it’s predicting immunotherapy response in melanoma or identifying relapse in neurological conditions, our work sits at the edge of scientific possibility and real-world application.

“At EVIIVE, innovation isn’t a department—it’s a team mindset. Every role contributes to a diagnostic future that’s faster, smarter, and radically more personal.”

About this startup

EVIIVE

Biotech · Zug Valley

Employees 1–10

Founded 2022