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Elos Medtech, a leader in medical technology, is seeking a Senior Specialist Regulatory Affairs for its sites in Muntelier and Yverdon-les-Bains. In this role, you'll lead the creation and maintenance of Technical Documentation and manage regulatory compliance across the product lifecycle.The ideal candidate will hold a degree in Engineering or Life...

pElos Medtech AB is seeking a Senior Specialist in Regulatory Affairs for its site in Muntelier. The role focuses on managing regulatory strategy, ensuring compliance throughout the product lifecycle, and leading documentation efforts. /ppThe ideal candidate will have a degree in Engineering, strong knowledge of European MDR and U.S. FDA regulations, and...

pElos Medtech AB is seeking a Senior Specialist in Regulatory Affairs located in Muntelier Yverdon-les-Bains, Switzerland. The role focuses on leading regulatory compliance activities and managing CE marking under MDR and FDA submissions. /ppThe ideal candidate has a degree in Engineering or Life Sciences and extensive Regulatory Affairs experience in the...

Elos Medtech AB is seeking a Senior Specialist in Regulatory Affairs located in Muntelier Yverdon-les-Bains, Switzerland. The role focuses on leading regulatory compliance activities and managing CE marking under MDR and FDA submissions.The ideal candidate has a degree in Engineering or Life Sciences and extensive Regulatory Affairs experience in the medical...

B. Braun Medical AG sucht Mitarbeitende zur Bedienung von Spritzgussanlagen an den Produktionsstandorten Sempach, Escholzmatt und Crissier. Sie beheben Störungen, führen GMP-/FDA-gerechte Qualitätsprüfungen durch und erfassen Barcodes der Fertigungsaufträge.Eine abgeschlossene Berufsausbildung oder einschlägige technische Erfahrung wird bevorzugt;...

pClinilabs seeks a Vice President of Quality Assurance to lead the quality and regulatory teams, shaping strategy for quality systems and compliant operations across clinical trials. You will ensure cGCP adherence, regulatory readiness, and harmonization of processes within the organization. /ppThis role requires deep GXP experience, strong leadership, and...

A leading life sciences consultancy is looking for a Regulatory Affairs Manager to oversee regulatory submissions, manage a team, and ensure compliance with EMEA and FDA regulations. Candidates should possess a minimum of 8 years in regulatory affairs, with at least 4 years in a managerial capacity. Excellent written and verbal English skills are essential...

gloor&lang AG in Basel, Switzerland, seeks a senior Regulatory Affairs professional to lead late-stage development regulatory strategies and NDA filings. You will consolidate regulatory expertise internally and drive filing readiness with cross-functional teams.The role emphasizes ownership of interactions with FDA/EMA, alignment across clinical, CMC and...

pDNDi and MMV are seeking a Senior Regulatory Sciences Manager to lead regulatory strategies for a joint platform spanning early development to access. The role is embedded across DNDi and MMV, reporting to the Directors of Regulatory Sciences, with interactions across EMA, FDA, Swissmedic and WHO, and a focus on patient access in LMICs. /ppThe candidate...

What to Expect Line management, training of Regulatory Specialist Training of direct reports in EMEA / FDA requirements Establish and manage regulatory submission timelines for both new and existing products across key global markets Engage with regulatory authorities and distribution partners to support product registrations Conduct global regulatory...

.joqReqDescription { max-width: 808px;}   Ypsomed is a leading Swiss medical technology company specializing in innovative injection systems for drug delivery. Headquartered in Burgdorf, Switzerland, the company combines decades of expertise in drug-device combination products and medical devices with a global footprint, serving pharma (partners or...

Fortil, groupe international d’ingénierie, recherche un ingénieur senior CQV pour renforcer son activité en Suisse (Genève). Vous piloterez la stratégie CQV des projets conformes GMP/FDA/EMA, tout en assurant l’interlocution client et le pilotage technique.Vous superviserez la documentation de qualification (VP, IQ/OQ/PQ, DQ, RAP) et les campagnes...

Gi Group in Basel seeks an experienced Senior Quality Lead with a strong background in pharmaceutical, biotech, or medical device industries. The role focuses on driving quality strategy, leading GxP audits, ensuring inspection readiness, and partnering with global stakeholders to uphold the highest quality and compliance standards.The position requires at...

Ophtapharm AG is an FDA/EU-GMP certified manufacturer in the pharmaceutical sector (ophthalmic products). At our production site in Hettlingen near Winterthur, high-quality products such as eye drops, ointments, and gels are aseptically produced, filled, and packaged for international markets. You play a central role in ensuring quality and compliance for...

DescriptionWe are looking for team players, who want to share their knowledge with our teamand improve their personal capabilities Background in analytical chemistry/ biochemistry/ life science Experience in the analytical-pharmaceutical environment, preferably experience inQA Skills to solve the problems and build a good relationship with various...

Die Wyon AG entwickelt und produziert mit heute 200 Mitarbeitenden kundenspezifische Lithium-Ionen-Batterien in Klein- und Mikrogrössen für medizinische Anwendungen. Durch patentierte und hoch innovative Technologien sind wir der Branche oft einen Schritt voraus; so ist Wyon AG heute Weltmarktführer in der Herstellung aufladbarer Batterien für...

ppbNotre client, une entreprise biotechnologique en forte croissance à Zürich, industrialise des lots cliniques et commerciaux dans un cadre EU/FDA GMP. Ambition claire: passer un cap d’excellence opérationnelle (Annexe 1, Data Integrity, PQR/APR, CAPA robustes) tout en gardant l’agilité d’une structure à taille humaine. Ils recherchent un(e)...

pFür unseren Kunden, ein innovatives Industrieunternehmen mit Fokus auf die Verarbeitung von Metallen und Kunststoffen sowie auf Montage-, Reinigungs- und Verpackungslösungen suchen wir zur Erweiterung des Teams eine qualitätsbewusste und engagierte Persönlichkeit. Dank hoher Fachkompetenz entlang der gesamten Wertschöpfungskette und zertifizierter...

Innovative Biopharmaceutical Company | Northwestern Switzerland Build and Lead Internal Regulatory Affairs Capabilities for Late-Stage Development and NDA Filing. Our client is an innovative, research-driven biotechnology company advancing a portfolio of novel small molecule therapies through late-stage clinical development. As the lead program approaches a...

In dieser Position sind Sie verantwortlich für die Sicherstellung eines effizienten, qualitätskonformen und termingerechten Produktionsablaufs unter Einhaltung regulatorischer Anforderungen der Medizintechnik (ISO 13485, MDR, FDA). Sie haben die Gelegenheit, Verantwortung für ein Team zu übernehmen und mit ihrem Talent für Organisation,...