IVD Regulatory Affairs Lead – Part-Time / Equity Eligible

Startupvalleys; Zürich; Vor Ort; CHF 120.000 - 180.000; Teilzeit

Benefits dieser Stelle

Part-time option

Consultant-like arrangement

Equity discussions

Zusammenfassung

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.

Qualifikationen

• 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

Aufgaben

• 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

Jobbeschreibung

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.