Gehaltsübersicht für Regulatory in Schweiz

Tasks & Responsibilities:         Project Lead Regulatory, within the scope of a project for new products or during the product lifecycle:Provides regulatory support to the R&D Project teams with the applicable Design Control processesProvides team members ad hoc specific education;Provides qualification and classification of the development object and related submission strategy;Interfaces with the correspondent RA-FL for submission strategies, planning and support;Escalates project related regulatory issues;Review of labellingAssemble the documents and the project deliverable (or coordinate the activities) for the preparation of worldwide registration and resolution of possible conflicts.Administration of Product declarations, Certificates and other, similar documents         Global Regulatory Affairs Manager - interaction with other regulatory functions:Ensure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest.Inform Global Regulatory Affairs Business areas about changesInform Global Regulatory Affairs Business areas about relevant issues during product development and life cycle management          Global Regulatory Affairs Manager - interaction with functions other than regulatory functions:Education of staff members of R&D and Portfolio Management on regulatory related topics (e.g. Regulations or changes in the regulations).Accomplish of conformity evaluation including compilation of the conformity declaration for new and existing products.Provide support for specific topic/questions           Global Regulatory Affairs Manager-General Task:Define and provide Training on Regulatory submission topicsMonitor regulatory requirements, including communication and distribution in a level appropriate mannerImplementation of divisional and local-strategies Requirements:Minimum 3/4 years in hands-on global regulatory affairs Experience in global regulatory affairs working on development projects in medical devices (MD or IVD) Experience in industry Experience with software (working with instruments) Master degree (microbiology or chemistry) or an engineering degree RWD knowledge / understandingExcellent communications and negotiations skills

 1)           Project Lead Regulatory, within the scope of a project for new products or during the product lifecycle:Provides regulatory support to the R&D Project teams with the applicable Design Control processesProvides team members ad hoc specific education;Provides qualification and classification of the development object and related submission strategy;Interfaces with the correspondent RA-FL for submission strategies, planning and support;Escalates project related regulatory issues;Review of labellingAssemble the documents and the project deliverable (or coordinate the activities) for the preparation of worldwide registration and resolution of possible conflicts.Administration of Product declarations, Certificates and other, similar documents 2)           Global Regulatory Affairs Manager - interaction with other regulatory functions:Ensure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest.Inform Global Regulatory Affairs Business areas about changesInform Global Regulatory Affairs Business areas about relevant issues during product development and life cycle management 3)           Global Regulatory Affairs Manager - interaction with functions other than regulatory functions:Education of staff members of R&D and Portfolio Management on regulatory related topics (e.g. Regulations or changes in the regulations).Accomplish of conformity evaluation including compilation of the conformity declaration for new and existing products.Provide support for specific topic/questions 4)           Global Regulatory Affairs Manager-General TaskDefine and provide Training on Regulatory submission topicsMonitor regulatory requirements, including communication and distribution in a level appropriate mannerImplementation of divisional and local-strategies Must haves:Minimum 3/4 years in hands-on global regulatory affairs Experience in global regulatory affairs working on development projects in medical devices (MD or IVD) Experience in industry Experience with software (working with instruments) Master degree (microbiology or chemistry) / engineering or programming degree RWD knowledge / understandingExcellent communications and negotiations skills Nice to haves:Fluency in Spanish

Description-Ensure compliance with regulations throughout product development.-Conduct regulatory research and prepare documentation for submissions.-Support regulatory audits and assist in strategy development.MotivationWould you like to be part of a pharmaceutical giant? We offer fair compensation, a great team, excellent benefits, and much more! What are you waiting for? Apply now!Company descriptionEin global agierendes Unternehmen im Bereich Gesundheitswesen, das sich auf innovative Lösungen in den Bereichen Pharma, Augenheilkunde und Generika spezialisiert hatSpecialThis position is temporary and contract-based. Extension and permanent employment are possible upon contract expiration!Experience-Bachelor's degree in a relevant field.-Prior regulatory affairs experience -general pharma knowledgeEducationLanguagesDeutsch: GutEnglisch: Sehr gutPlace of workBaselStart of workNach VereinbarungAlterOffenVacancy no.P-19-3813

Regulatory Affairs DirectorResponsibilities Job Description Summary Job Description Our vision for Regulatory Affairs at BD The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric attitude. About the role As Regulatory Affairs Director you will define, develop and lead global strategies to improve global regulatory success towards achievement of program objectives for complex projects. In this role you will ensure global regulatory plans accommodate appropriately achievement of business objectives and optimally communicates with project teams, line management and key partners on any developments that may impact regulatory success. Main responsibilities will include: Provide innovative ways, strategic and tactical mentorship to resolve regulatory issues and increase speed to market Ensure high quality collaboration with Regional Regulatory partners by providing timely guidance and partnership in health authority meetings and regulatory documentation spanning throughout the product lifecycle Provides guidance on planning, writing and review of dossier documents for submissions globally Represent BD in interactions with health authorities for the product portfolio assigned Lead cross-functional stakeholder alignment to drive robust regulatory submissions Remains on the forefront of the relevant science and competitive landscape via actively contribution to policy shaping efforts including partnering with trade associations; viewed as an expert in its application to the regulatory process Coach and mentor team, create an open, inclusive environment for associates to grow and challenge themselves About you We are looking for experienced leader in Medical Device Regulatory Affairs with expertise in global regulatory requirements and standards applicable to medical devices (software-hardware integrated technologies, apps, cloud solutions, digital tools) e.g., ISO13485, QSR, EU MDR, US FDA – 510k and PMA. Your attributes include: Knowledge of and experience in pre-market regulations including regulatory and risk management processes Experience in all regulatory compliance aspects of the business: pre-market, commercial, and post-market Excellent verbal and written communications skills. Strong project coordination, business acumen and negotiation abilities Ability to lead, develop and empower multi-cultural and multi-national teams Click on apply if this sounds like you! Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. To learn more about BD visit: https://bd.com/careers Primary Work Location CHE Eysins - Business Park Terre-Bonne Additional Locations Work Shift ApplySave Job

Für den Ausbau unserer Abteilung Regulatory Affairs suchen wir nach einem talentierten Regulatory Affairs Manager für den Bereich NMPA China. Du übernimmst eine zentrale Rolle bei der Koordination und Durchführung von Zulassungsprozessen für Oertli Produkte in China und der EU. Dein Wissen im Bereich Regulatory Affairs und deine Fähigkeit, komplexe regulatorische Anforderungen zu bewältigen, werden dazu beitragen, dass unsere Produkte reibungslos auf den Markt gelangen.Regulatory Affairs Manager - NMPA (China)Das kannst Du bewirkenDu bist verantwortlich für die Erstellung und Pflege der Zulassungsdokumentation, um einen reibungslosen Markteintritt sicherzustellen Gewährleistest die Einhaltung der regulatorischen Anforderungen gemäss NMPA (China) und MDR (EU) Koordination und Zusammenstellung von Unterlagen für länderspezifische Registrierungsprozesse, insbesondere in China Erstellung und Bearbeitung der Zulassungsanträge, Änderungs- und Verlängerungsanträge gemäss den entsprechenden Richtlinien Aktive Beteiligung an Konformitätsbewertungsverfahren Identifizieren und Überwachen von produktspezifischen und länderspezifischen regulatorischen Anforderungen Kommunikation mit Behörden und externen Dienstleistern im Rahmen der Zulassungsaktivitäten Integration neuer regulatorischer Anforderungen in bestehende Prozesse Unterstützung der Fachabteilungen bei der Auslegung und Umsetzung regulatorischer Anforderungen Pflege und Entwicklung interner und externer Datenbanken Erarbeitung von Strategien für Zulassungen in China sowie enge Zusammenarbeit mit unseren externen ConsultantDas zeichnet Dich ausDu verfügst über ein abgeschlossenes Studium im Bereich Medizintechnik, Naturwissenschaften oder einer ähnlichen Fachrichtung Erste Berufserfahrung im Bereich Regulatory Affairs vorzugsweise im Medizinproduktesektor Gute Kenntnisse der Regularien EU-MDR sowie vorzugsweise der Regularien China-NMPA Erste Erfahrung in der Vorbereitung und Einreichung von Zulassungsanträgen von Medizinprodukten in China gemäss NMPA Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift (Sprachkenntnisse der chinesischen Sprache sind willkommen) Persönlichkeit mit viel Eigenverantwortung gepaart mit einer selbständigen Arbeitsweise Starke organisatorische Fähigkeiten und ein Auge für das Detail Reisebereitschaft 15-20% (international, China)Was Dich bei uns erwartetEine offene Du-Kultur und ein familiäres Miteinander Eine ausführliche Einarbeitung sowie ein individuell gestaltetes Einführungsprogramm mit Einblick in verschiedene Abteilungen Eine sinnstiftende Arbeit, welche das Leben anderer verbessert Mindestens 5 Wochen Ferien sowie Vorholtage flexible Arbeitszeiten und die Möglichkeit, teils bequem aus dem Homeoffice zu arbeiten Unterstützung der beruflichen Weiterentwicklung durch gezielte Aus- und Weiterbildungen Übernahme der Krankentaggeldprämie Kostenlose Parkplätze Kostenlosen Kaffee, Tee und frischen Früchte sowie 15 Minuten bezahlte PauseWeiter Informationen zu unseren Zusatzleistungen findest du hier.Das sind WirIm St. Galler Rheintal entwickelt und produziert die Oertli Instrumente AG modernste Geräte und Instrumente für die Augenchirurgie. Ob in hochmodernen Augenkliniken in Europa, in spezialisierten Kompetenzzentren im arabischen Raum oder bei mobilen Hilfsprojekten im Himalaya – überall tragen unsere Produkte und Lösungen dazu bei, Augenärzte und OP-Personal bei der Erhaltung von Augenlicht und bei der Verbesserung der Sehfähigkeit zu unterstützen.Bereit, die Welt des Augenlichts zu verändern? Dann freuen wir uns auf Deine vollständigen Bewerbungsunterlagen.Für Fragen steht Dir Fabio (HR Business Partner) gerne unter +41 71 747 42 03 zur Verfügung. Direktbewerbungen werden bevorzugt.Arbeitsort: 9442 Berneck (Home Office möglich)18.01.2024 Regulatory Affairs Manager NMPA (China) 9442 Berneck Festanstellung 80-100% Alle Jobs dieses Anbieters  Meinen Arbeitsweg berechnenJETZT BEWERBENÜber uns Jobs KarriereBenefitsFotos / Videos Website Seit der Unternehmensgründung im Jahr 1955 hat sich Oertli von einer Werkstatt für chirurgische Instrumente zu einem der weltweit führenden Anbieter von Geräten und Instrumenten in der Augenchirurgie entwickelt. Die Geschichte von Oertli ist reich an Innovationen, Highlights und wissenschaftlichen Erfolgen. MehrBewerbungsservices Bewerber-Cockpit anlegen  Bewerbungsvideoaufnehmen  Kandidatenprofil erstellenund von Firmen finden lassen  Bewerbungsfoto mit KI erstellen  Zum BewerbungsratgeberMaking the difference with you

 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. You will ensure CMC dossiers of the site commercial and development products are consistent and compliant with the site activities and will coordinate the site review of quality (Quality/CMC) sections for clinical trials applications or worldwide submissions. You will also ensure the site right to operate through successful inspections from Health Authorities and audits from partners and the global functions. Your role:Site Regulatory compliance activities:Ensure Quality/CMC consistency and compliance by liaising with the Global Regulatory Affairs department. You will support the establishment of Regulatory reporting (e.g. Annual Reports) and Regulatory Affairs requests (e.g. renewals process, statements, GMP certificates).be involved in the Change Control Proposals (CCPs) from a regulatory perspective.Provide the regulatory status overview for products portfolio to the Qualified Person of the site in the frame of product disposition process. Inspection Readiness activities:Lead the site Quality inspections readiness program, from notification by the inspection body until approval of the CAPA planCentral member of the audit/inspection hosting teamCoordinate and follow-up the definition and execution of CAPA plansWho you are:•Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)•You have at least 5-7 years of experience in the pharmaceutical industry•You have at least 5 years of experience in global CMC regulatory affairs, and quality assurance / compliance, inclunding experience in inspection readiness.•Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, or International)•Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or a large variation•Good knowledge in biotechnological sciences, manufacturing of biologics and related regulatory guidelines (cGMPs, 21 CFR, etc.)•​​​​​​​​​​​​​​Excellent written and spoken communication skills in French and English What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team! Über das Unternehmen:Merck KGaA Darmstadt, GermanyBranche:Pharmaceutical, CAPA, QA, Inspector, Quality Assurance, Science, Management, Quality, Technology

Für unseren Kunden, ein globales Pharmaunternehmen mit Sitz in Zug, suchen wir eine/n Regulatory Affairs Coordinator 80-100%.Job DescriptionUnterstützung des Regulatory Affairs Managers und eigenständiges Projektmanagement Zeitnahe Vorbereitung und Umsetzung der Verpackung und Veröffentlichung von Informationen zu Arzneimitteln Koordination mit dem Hersteller bezüglich der Verpackung Koordination von Übersetzungen Unterstützung des Regulatory Affairs Managers bei der Einreichung und Koordination von neuen Zulassungen oder Änderungsanträgen bei Swissmedic Bearbeitung von Standarddokumenten Unterstützung bei der internen und externen Meldung von Nebenwirkungen, Qualitätsmängeln und medizinischen Anfragen Wartung der Systeme Ansprechpartner für externe Dienstleister Allgemeine administrative Unterstützung des Regulatory Affairs Managers The Successful ApplicantAbgeschlossene Berufsausbildung mit paramedizinischem Hintergrund (z. B. Pharmazeutisch-technischer Assistent, PTA, Drogist, MPA usw.) Mindestens drei Jahre Erfahrung im Bereich Regulatory Affairs in der Schweiz (Arzneimittelzulassung, Qualitätssicherung in der pharmazeutischen Industrie) Fliessendes Deutsch und Englisch, Französisch und Italienisch wären von Vorteil Gute MS-Office-Kenntnisse Selbstständige, präzise und lösungsorientierte Arbeitsweise Proaktiver Teamplayer mit guten organisatorischen Fähigkeiten Zuverlässigkeit und hohes Verantwortungsbewusstsein Starke Kommunikation- und zwischenmenschliche Fähigkeiten What's on OfferMöchten Sie Teil eines internationalen Unternehmens sein, in dem Sie eine Stimme und einen Einfluss haben? Dann bewerben Sie sich jetzt online!ContactCaroline BourgouinQuote job refJN-022024-6331201Job FunctionHealthcare & Life SciencesSpecialisationRegulatory AffairsIndustryHealthcare / PharmaceuticalLocationZugContract TypePermanentConsultant nameCaroline BourgouinJob ReferenceJN-022024-6331201Job NatureHome OfficeMichael Page Vakant seit : 11.02.2024 6300 Zug (ZG) 80% - 100% Nach Vereinbarung Unbefristet Startup-Mentalität in einem globalen Pharmaunternehmen Relevante lokale Erfahrung (Swissmedic) About Our Client

Regulatory Affairs Manager (f/m/d) The Global Regulatory Affairs department of the B. Braun Avitum division has an opportunity for a Regulatory Affairs Managerlocated at our site in Sempach, Switzerland. In our plant in Sempach, we develop and produce a broad range of products for cleaning and disinfecting instruments, biocidal products for hand and surface disinfection as well as medicinal products for use on skin and in wounds. Diversity is a part of B. Braun Avitum AG. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.We are looking for a passionate and talented individual who will act as an entrepreneur of the global infection preventionportfolio. Find out more about our Sempach site. and why it is worth working for B. Braun. Tasks & Responsibilities Worldwide marketing authorisation and regulatory support for biocides and cosmetics Creation of regulatorydocumentation (R4BP, PIF) for acquiring and maintaining registrations Handle variations to the dossier in accordance with the Change Control process Prepare responses to requests by the Competent Authorities during the evaluation process, and timely handle deficiency letters within a specific timeframe Create and maintain a full up-to-date database and archiving system for tracking the local Regulatory dossiers in the region Effective communication and cross-functional interaction with all involved departments, both on a Regional and Global levels (Regulatory Affairs, Quality Assurance, Quality Control, Production area, Medical Affairs, Marketing) Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/Medical Affairs Build collaborative relationships with decision-makers and opinion leaders to understand current issues and recognize future trends in the market Professional skills University education in the natural sciences (pharmacy, chemistry, biology) Further training in the area of regulatory affairs (EU, CH, USA, Asia) would be an advantage Experience in the registration of biocides and cosmetics Very good written and spoken English and German skills (any additional skills are beneficial) Personal skills Analytical and structured way of thinking and working High organizational and communication skills Good teamwork and interpersonal skills What we offer Our promise is Sharing Expertise. The B. Braun company began with a passion for positive change. To this day, we attract people who express progressive ideas and implement them together with trust, transparency and appreciation. Because all follow the same vision: At B. Braun, we protect and improve the health of people worldwide.

Support team members in creating CE Mark submissions and change notifications to our Notified Body (NB), including responding to regulatory inquiriesAid in the completion and upkeep of Technical Documentation for CE Mark, following regulatory requirements and best practicesStay informed of regulatory and standards changes, assisting in updating company policies and procedures to maintain complianceProvide regulatory support to cross-functional teams by interpreting regulatory requirements into actionable plansParticipate in process improvement projects to increase the efficiency and effectiveness of regulatory proceduresAssist in addressing regulatory questions from internal stakeholders such as Customer Service,Contracts/Tenders, Sales, and Marketing, providing clear and accurate regulatory guidanceSupport the Regulatory Affairs team by managing administrative duties related to regulatory submissions, including coordinating the signing of documents, maintaining records, and ensuring that all regulatory documents are properly archived and accessibleSupport in implementing and maintaining the Quality Management System, such as CAPA, Management Review, and auditsParticipate in internal/external audits and inspections, ensuring that company procedures, processes, and documentation meet the requirements of the Quality Management System, ISO 13485, and other applicable regulationsOffer regulatory support to other departments such as R&D, engineering, and clinical affairs as needed1-3 years of experience in regulatory affairs and/or quality compliance within the medical device sector, focusing on adherence to EU regulationsA Bachelor's degree in Engineering, Medical Technology, or a closely related field, or equivalent practical experience in a similar roleBasic understanding of global medical device regulations, including ISO 13485, the European Medical Device Regulation (2017/745/EU)Familiarity with EU submissions for new products and sustaining activitiesStrong organizational and planning skills, with a proactive approach to problem-solvingEffective interpersonal abilities, capable of working collaboratively within international teams and across departmentsFluent in English, with a minimum of C1 level proficiency for clear and effective communicationEarly-stage knowledge of US FDA 21 CFR 820.30 and 510(k) submissions is a plus.

Support Regulatory Surveillance process with regards to local EU regulation(s); support RA intelligence and regulatory surveillance processActively engage in process improvement initiatives to streamline and optimize the regulatory process and QMS procedures (commercial site and European region's management review)Support local team in documentation change control management and record managementPartner with Change Control department to provide change control & documentation control guidance to the European sitesCollaborate in the elaboration of in classroom training materials related to compliance topics (CAPA, audit readiness)Supports Quality Management system activities, such as CAPA, quality plans and auditsParticipates in internal/external audits and inspections, and ensures that company procedures, processes and documentation meet the requirements of the Quality Management System, ISO 13485 and other applicable regulationsSupports process improvement and implementation of regulatory projects and toolsGood Knowledge/understanding of the EU Medical Device Regulation (EU) 2017/745 and European Medical Device Directive 93/42/EEC, Swiss Medical Device Regulation (MedDO)Knowledge of Medical Device registration requirements in Europe and EUDAMEDKnowledge of product EU regulations or directives (e.g. RED, ROHS, Swiss MedDO, …)General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)3-5 years of experience in a Medical Device Quality or regulatory compliance / Quality system department.A Bachelor's or Master's degree in medical technology, life sciences or similar (or equivalent work experience in similar function)Experience in documentation control & record management (preferred)