Auf einen Blick
- Aufgaben: Entwickle und leite die globale Regulierungsstrategie für innovative Medizintechnologie.
- Unternehmen: Apersys AG, ein zukunftsorientiertes Medtech-Unternehmen in Zürich.
- Vorteile: Hybrides Arbeiten, wettbewerbsfähiges Gehalt und Beteiligung am Unternehmen.
- Weitere Informationen: Kleine, dynamische Teamstruktur mit direktem Zugang zu den Gründern.
- Warum dieser Job: Gestalte die Regulierungslandschaft für bahnbrechende medizinische Geräte und mache einen echten Unterschied.
- Qualifikationen: Mindestens 7 Jahre Erfahrung in der Regulierungsbehörde für Medizinprodukte, idealerweise mit Class III Geräten.
Das prognostizierte Gehalt liegt zwischen 85500 - 104500 € pro Jahr.
- pp Apersys AG
- Zurich (Oerlikon), hybrid
- Full-time /p h3Senior Manager Regulatory Affairs /h3 h3About Apersys /h3 p Apersys is a Zurich-based medtech company developing the world's first multi-day normothermic machine perfusion platform for liver transplantation.
Spun out of ETH Zurich and University Hospital Zurich, and holding FDA Breakthrough Device Designation, we're building technology that keeps donor livers viable outside the body for days rather than hours expanding the pool of transplantable organs and reshaping what's possible in transplant medicine. /p h3The Role /h3 p We're hiring for the Senior Manager Regulatory Affairs role to own our global regulatory strategy and drive the pathway to market for our first-in-class Class III medical device.
This is a build role shaping how we engage with FDA and EU regulatory bodies and setting the regulatory foundation for a platform that will scale across markets. /p p Reporting to the CEO. /p h3What you'll do /h3 ul li Develop, own and execute Apersys' global regulatory strategy, with FDA as the primary near-term focus (BDD, IDE, PMA).
/li li Serve as our primary regulatory interface with FDA, lead negotiations on regulatory issues, and manage authority interactions end-to-end.
/li li Lead regulatory pre-Sub and submissions for a Class III device with Class C software throughout development and life-cycle management.
/li li Act as Person Responsible for Regulatory Compliance (PRRC), ensure device conformity, maintain technical documentation, and oversee post-market surveillance and vigilance reporting.
/li li Participate actively in design control across hardware, software, sterility, biocompatibility, and electrical safety; ensure regulatory strategy shapes development decisions early.
/li li Own regulatory review of labelling, IFU, artwork, and promotional materials.
/li li Monitor and interpret the evolving FDA, EU MDR, and international regulatory landscape; translate what matters into internal decisions.
/li li Support Notified Body interactions and audits alongside the quality function.
/li li Provide regulatory input to clinical, engineering, and commercial teams as we scale.
/li
/ul h3What we're looking for /h3 ul li Degree in engineering, life sciences, or medicine; formal regulatory training (RAC or equivalent) preferred.
/li li7+ years in medical device regulatory affairs, with demonstrated ownership of Class III / PMA submissions. Breakthrough Device pathway experience is a strong plus.
/li li Direct experience preparing and filing FDA submissions (Pre-Sub, IDE, PMA); comfortable leading FDA interactions.
/li li Working knowledge of EU MDR technical documentation and Class III conformity assessment.
/li li Fluency with the core standards ecosystem: 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62366.
/li li Meets EU MDR Article 15 PRRC eligibility (formal qualifications plus regulatory experience, or 4+ years' equivalent).
/li li Experience with IEC 62304 Class C software in a regulated device context is nice to have.
/li li Previous experience in managing a QMS and quality activities is nice to have.
/li li Fluent English.
/li li Comfortable building systems from scratch in a small, fast-moving team.
/li
/ul h3Why Apersys /h3 ul li Build the regulatory function from the ground up on a Breakthrough-designated Class III platform; technically ambitious, clinically meaningful work.
/li li Small team (~10 people), close founder access, real influence on strategy.
/li li Zurich-based with hybrid working; competitive package including equity participation.
/li
/ul h3Location how to apply /h3 p Zurich (Oerlikon), hybrid. Full-time. /p p Investigational device, not yet cleared or approved for commercial use. /p /p #J-18808-Ljbffr
Senior Manager Regulatory Affairs Arbeitgeber: Apersys AG
pApersys AG in Zürich bietet eine inspirierende Arbeitsumgebung, in der Innovation und Teamarbeit im Mittelpunkt stehen. Als Arbeitgeber im Bereich der Medizintechnik fördern wir nicht nur die persönliche und berufliche Weiterentwicklung unserer Mitarbeiter, sondern bieten auch attraktive Vorteile wie flexible Arbeitszeiten und die Möglichkeit, an einem lebenswichtigen Produkt zu arbeiten, das das Leben von Patienten verbessert. Unsere Unternehmenskultur ist geprägt von Offenheit und Zusammenarbeit, was es Ihnen ermöglicht, Ihre Ideen einzubringen und einen echten Unterschied zu machen.
