17 meilleures offres (regulatory affairs, nyon vd) (à pourvoir)

Associate Director, Regulatory Affairs - Digital Health, Device & Combination Products (all gender)
Merck KGaA —Eysins, VD
- Niveau Doctorat
- Anglais
- Niveau Master
- Opportunités de carrière
il y a 12 jours
Manager, Professional Education
Edwards Lifesciences —Nyon, VD
- 100%
- Gestion du personnel
- Anglais
- Niveau Master
- Formation sur place
VP, Europe (APM)
BD —Eysins, VD
- Gestion du personnel
- Anglais
- Microsoft Office
Programme Officer (Partnerships), DSIT/WYVC, P3
International Trade Centre (ITC) —Genève, GE
- Espagnol
- Gestion du personnel
- Anglais
6 h
Regulatory and Compliance Expert
Axepta —Le Vaud, VD
- Anglais
- Technologies de l'information
Director HEOR EMEA Region
BD —Eysins, VD
- De 182 900 CHF à 292 625 CHF par an
- Télétravail
- Niveau Doctorat
- Recherche
- Esprit d'analyse
GFCC Screening Officer - Associate
JPMorganChase —Genève, GE
- 100%
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
il y a 5 jours
Chief Compliance Officer
SZ1 Banco Santander International SA —Genève, GE
- 100%
- Espagnol
- Gestion du personnel
- Anglais
Quality Control Manager
ADM —Rolle, VD
- 100%
- Expérience en laboratoire
- Anglais
- Niveau Licence
Process Validation Engineer
Skillhubs —Genève, GE
- 100%
- Travail hybride
- Anglais
- Production
- Compétences en communication
Postuler rapidement
Senior Medical Director, Solid Tumors, International
Incyte Corporation —Morges, VD
- Niveau Doctorat
- Anglais
- Compétences en communication
New Energy Safety and Rescue Manager
FEDERATION INTERNATIONALE AUTOMOBILE —Genève, GE
- Anglais
il y a 14 jours
Director Marketing Surgery EUROPE
BD —Eysins, VD
- Déplacements à prévoir jusqu'à 50%
- Technologies de l'information
- Leadership
il y a 8 jours
Marketing & Communication Coordinator (GER/ENG/FR)
Teoxane —Genève, GE
- Anglais
- Gestion de projet
- Niveau Licence
Global Lead ATM and Airport policy
International Air Transport Association (IATA) —Genève, GE
- Anglais
Senior Medical Director, Global Risk Management & Safety Surveillance
Incyte Corporation —Morges, VD
- Niveau Doctorat
Group Patent Counsel
Verisure Sàrl —Genève, GE
- 100%
- Anglais
- Gestion de projet
- Compétences en communication
Postuler rapidement

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Auctae Switzerland Sàrl —Genève, GE
Rigoureux et organisé, vous avez évolué dans un environnement réglementé lié aux dispositifs médicaux. Travaillez en étroite collaboration avec les équipes R&D,…
Specialiste affaires réglementaires
Axepta —Lausanne, VD
Notre client, une entreprise pharmaceutique à taille humaine, recherche actuellement un spécialiste en affaires réglementaires pour une mission de minimum 10…

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Associate Director, Regulatory Affairs - Digital Health, Device & Combination Products (all gender)

Merck KGaA -
Eysins, VD

Soumettre votre candidature

Détails de l'emploi

Il y a 12 jours

Avantages

Opportunités de carrière

Qualifications

Niveau Doctorat
Anglais
Niveau Master

Description complète du poste

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role: In this pivotal role, you will own and drive the global regulatory strategy for drug-device combination products, shaping the pathway from early development through to approval and lifecycle management. You will serve as the Device Regulatory Lead within a cross-functional regulatory strategy team, working in close partnership with CMC, device engineering, and quality colleagues to ensure compliant, timely, and scientifically credible submissions to health authorities worldwide. Your ability to build trusted relationships with regulatory agencies and to translate complex regulatory requirements into clear, actionable strategies will be central to accelerating the development of innovative combination products. Operating with considerable autonomy, you will influence both internal decision-making and external regulatory outcomes, contributing to a culture of regulatory excellence and risk-based thinking across the R&D organization.

Who You Are:

You hold a degree in a life science or related discipline (MSc minimum or equivalent); a higher degree such as a PhD in a scientific discipline is preferred.
You bring 10 or more years of regulatory affairs experience, with proven and recent expertise in drug-device combination product submissions and/or medical devices for US, EU, and international markets.
You have a demonstrated ability to develop global regulatory strategies and assemble dossiers for submissions including EU MAA, NBOp, CTA, US IND, NDA, BLA for combination products, 510(k), and PMA; international experience is strongly preferred.
You have a proven track record of productive collaboration with regulatory authorities through scientific advice meetings, and you are able to act as a credible, influential spokesperson during such interactions.
You possess a solid understanding of the drug-device combination and medical device regulatory framework across EU, US, and international markets, including ICH, EU-MDR, MDSAP, ISO 13485, cGMP for combination products, QMS, technical file requirements, eCTD, and MCDG guidelines.
Prior experience with regulatory CMC and connected drug-device combination products for medicinal products is an advantage.
You are a strong team player who thrives in a highly multidisciplinary environment and communicate effectively with colleagues and stakeholders from diverse professional backgrounds.
You are fluent in English; proficiency in additional languages is an asset.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

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regulatory affairs emplois - nyon vd

Associate Director, Regulatory Affairs - Digital Health, Device & Combination Products (all gender)

Manager, Professional Education

VP, Europe (APM)

Programme Officer (Partnerships), DSIT/WYVC, P3

Regulatory and Compliance Expert

Director HEOR EMEA Region

GFCC Screening Officer - Associate

Chief Compliance Officer

Quality Control Manager

Process Validation Engineer

Senior Medical Director, Solid Tumors, International

New Energy Safety and Rescue Manager

Director Marketing Surgery EUROPE

Marketing & Communication Coordinator (GER/ENG/FR)

Global Lead ATM and Airport policy

Senior Medical Director, Global Risk Management & Safety Surveillance

Group Patent Counsel

Discover related jobs

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