fda

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, 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. /ppThe ideal candidate will hold a degree in Engineering or Life...

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...

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...

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,...

ph3What to Expect /h3 ul liLine management, training of Regulatory Specialist /li liTraining of direct reports in EMEA / FDA requirements /li liEstablish and manage regulatory submission timelines for both new and existing products across key global markets /li liEngage with regulatory authorities and distribution partners to support product registrations...

We are Specto Medical, a medical software company building immersive visualization tools for medical imaging data. Our flagship product, Specto, lets surgeons and clinicians inspect CT and MRI scans in mixed and virtual reality, giving instant spatial understanding of patient anatomy. Specto is FDA-cleared and CE-marked, and our eQMS is ISO 13485 certified....

pClinilabs is seeking a Global Project Manager to oversee cross-functional, multi-regional CNS clinical trials from protocol concept to final study report, ensuring timelines, budget and quality. /ppYou will lead client communications, vendor management and risk mitigation, collaborate with regulatory, data management and medical science teams, and drive...

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 impact...

icotec entwickelt und produziert hochfeste Implantate aus kohlefaserverstärktem Kunststoff für die Wirbelsäulenchirurgie. Als Senior Design Engineer arbeiten Sie eng mit dem internationalen Team am Standort Altstätten und tragen zur weltweiten Marktführerschaft bei.Sie gestalten innovative Produkte, erstellen CAD-Modelle (NX), führen Prototyping,...

Innovative Biopharmaceutical Company in Northwestern Switzerland is seeking an experienced Regulatory Affairs CMC professional to shape global regulatory strategy for innovative small molecule therapies.You will lead CMC activities across clinical development through registration, preparing Module 3 documentation and coordinating submissions with FDA, EMA...

gloorlang 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...

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...

Roche is seeking a Senior Regulatory Affairs Leader to guide a global team across regulatory strategy, submissions, and lifecycle management. You will mentor 10–15 staff, collaborate with FDA and international regulators, and drive standardized processes while promoting Agile leadership and cross-functional partnerships.Based in the global organization,...

pGI Life Sciences recherche pour son partenaire dans le canton de Neuchâtel un(e) Principal Scientist – MST Produits Parentéraux. Poste temporaire de 6 mois, référent technique pour les activités de fabrication externalisées et le transfert de procédés vers les sites externes (CMO). /ppVous piloterez les transferts de technologie, validations et...

Roche is seeking a Senior Regulatory Affairs Leader to guide a global team across regulatory strategy, submissions, and lifecycle management. You will mentor 10–15 staff, collaborate with FDA and international regulators, and drive standardized processes while promoting Agile leadership and cross-functional partnerships.Based in the global organization,...

Headcount is seeking a Director of Regulatory Affairs CMC Europe to lead the regulatory strategy for novel small-molecule therapies in oncology. This role requires steering global CMC development, submissions and lifecycle management across clinical, regulatory and manufacturing functions, with a focus on Module 3 and interactions with FDA/EMA.The candidate...

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...