Regulatory Affairs Manager, Cmc

vor 1 Woche

Linz, Oberösterreich, Österreich Corza Medical Vollzeit

Vacancy Name

  • Regulatory Affairs Manager, CMC

Location of Work

  • Linz, Austria

Employment Type

  • Full Time Employee
  • At Corza Medical, our mission is to support surgical providers with remarkable service, trusted performance, and outstanding value by creating an unmatched experience that stems from listening to the surgical experts themselves.
  • Our product family is the result of years of experience championing surgeons and listening to their expertise. We deliver unmatched value across our line of products and offer a seamless, personalized experience designed around surgeons' needs. We're a team of experienced professionals who understand the difference that excellent customer service can make.
  • We are seeking a Regulatory Affairs Manager, CMC to oversee the Regulatory Affairs CMC activities for our Linz, Austria facility.
    What we value
  • Integrity. _We do what is right._
  • Accountability. _We do what we say._
  • Customer First. _We deliver extraordinary experiences._
  • One Global Team. _We before me, always._
  • Inspired. _We love what we do._

What you will do

  • Review key documents before submission (e.g. MA Transfers, MAAs, variations, supplements etc.), ensuring their regulatory compliance.
  • Evaluate change proposals for regulatory impact and filing requirements.
  • Interfaces with other functions/departments to assess compliance of proposed claims and labelling submissions.
  • Strategic input, guidance on global regulatory requirements and potential risk anticipation.
  • Provides advice on regulatory issues; and collaborates with management and cross functional colleagues (i.e., Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments).
  • Provide experience interpretation and oversight of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.
  • Support Compliance and QMS operational activities (QE, CAPA, GxP Training, etc.) and is a point of contact for Regulatory CMC on audits & inspections.
  • Ensures global compliance and stays up to date on current global regulatory requirements, legislation, best practices, sharing knowledge cross functionally with key stakeholders to ensure regulatory success.

What you will need

  • Strong scientific qualifications.
  • Relevant experience in CMC Regulatory Affairs in pharma and/or medical devices.
  • Experience across EMEA and possibly the USA.
  • Experience providing strategic regulatory advice for the global development of products.
  • SCMC and scientific advice experience.
  • Understanding of GMPs, GLPs, GCPs and ICH /EMA guidelines; solid understanding of where to seek and how to interpret regulatory information.
  • Ability to manage complex issues and coordinate multiple projects simultaneously.
- eCTD and electronic managements system experience.

  • Strong written, verbal, listening, and communication skills.
  • The ability to collaborate effectively with and lead crossfunctional teams.
  • Experience with trending and analysis reporting.
  • Project leadership skills.
  • Process improvement and management skills.
  • Able to influence across the organisation.

What you will like
We foster a work environment where all team members are empowered and encouraged to share their opinions and ideas. We encourage robust, fact-based debate.

Our highly collaborative work environment results in the best decisions for Corza Medical and a shared mission to execute our plan together, on time and on budget.


Join our team
At Corza Medical, we are motivated by enabling our customers' success. That starts with understanding their needs and developing products that enhance clinical outcomes.

Our goal is to provide innovative, high-quality products and service that will ensure the continued success of our company and surgical professionals well into the future.

  • Lead Regulatory Affairs

    vor 1 Woche

    Linz, Oberösterreich, Österreich Thermo Fisher Scientific Vollzeit

    Thermo Fisher Scientific Inc (NYSE:TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their...

  • Regulatory Affairs Manager

    vor 1 Woche

    Linz, Oberösterreich, Österreich Tecan Vollzeit

    **Join Tecan Join the market leader****Work in an international and dynamic environment, share our success**Hast du dich jemals gefragt, wie deine Fähigkeiten und dein einzigartiger Hintergrund die Welt von morgen beeinflussen kann? Werde ein Teil unserer Teams und setze das Talent und die Leidenschaft, die dich ausmachen, bei uns ein als**Regulatory...

  • Lead Regulatory Affairs

    vor 1 Woche

    Linz, Oberösterreich, Österreich Thermo Fisher Scientific Vollzeit

    Thermo Fisher Scientific Inc (NYSE:TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their...

  • Regulatory Affairs Manager

    vor 1 Woche

    Linz, Oberösterreich, Österreich CompuGroup Medical Vollzeit

    Gestalte mit uns die Zukunft von e-health als Regulatory Affairs Manager (m/w/d)Als e-health Pionier schlägt unser Herz für die Entwicklung und Umsetzung neuer Technologien. Du möchtest Dein Engagement und Dein Know-How einbringen, aktiv ausbauen und als Team gemeinsam Fortschritte erzielen? Dann bist Du bei uns genau richtig Neben einem großartigen Team...

  • Lead Regulatory Affairs

    vor 1 Woche

    Linz, Oberösterreich, Österreich Thermo Fisher Scientific Vollzeit

    The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that...

  • Regulatory Affairs Manager

    vor 1 Woche

    Linz, Oberösterreich, Österreich Tecan Vollzeit

    **Join Tecan Join the market leader****Work in an international and dynamic environment, share our success****Hast du dich jemals gefragt, wie deine Fähigkeiten und dein einzigartiger Hintergrund die Welt von morgen beeinflussen kann? Werde Teil unserer Teams und setze das Talent und die Leidenschaft, die dich ausmachen, bei uns ein als****Regulatory...

  • Regulatory Affairs Manager

    vor 1 Woche

    Linz, Oberösterreich, Österreich Fresenius Kabi Austria GmbH Vollzeit

    **Ihr Aufgabengebiet**:- Erstellen von Dossiers (Modul 1 bis 5) für Neueinreichungen und Life Cycle Management-Aktivitäten im Format eCTD sowie weitere mit der Arzneimittelzulassung verbundene Aufgaben- Intensive Zusammenarbeit mit Behörden, Geschäftspartnern und internen Fachabteilungen- Dokumentenmanagement, Datenbankmanagement- Sicherstellung des...

  • Regulatory Affairs Manager Job Details Tecan

    vor 1 Woche

    Linz, Oberösterreich, Österreich Tecan Austria GmbH Vollzeit

    **Hast du dich jemals gefragt, wie deine Fähigkeiten und dein einzigartiger Hintergrund die Welt von morgen beeinflussen kann? Werde Teil unserer Teams und setze das Talent und die Leidenschaft, die dich ausmachen, bei uns ein als****Regulatory Affairs Manager (w/m/d)**Grödig, Salzburg**Dein Beitrag**In dieser vielseitigen Rolle bist Du mitverantwortlich...

  • Quality Assurance Representative M/w/d

    vor 1 Woche

    Linz, Oberösterreich, Österreich Thermo Fisher Scientific Vollzeit

    Thermo Fisher Scientific Inc. ist das weltweit führende Unternehmen im Dienste der Wissenschaft mit einem Jahresumsatz von rund 40 Milliarden US-Dollar. Unsere Mission ist es, unsere Kunden dabei zu unterstützen, die Welt gesünder, sauberer und sicherer zu machen. Wir unterstützen unsere Kunden, die biowissenschaftliche Forschung voranzutreiben, bei der...

  • Business Systems Manager

    vor 1 Monat

    Linz, Oberösterreich, Österreich Proclinical Vollzeit

    Proclinical is currently assisting a Medical Technology client based in Linz, Austria in the search for a Business Systems Manager to join their Business Applications team. The ideal candidate will have the opportunity to play a key role in improving business and manufacturing processes. This position calls for a proactive individual who can manage system...

  • Business Systems Manager

    vor 3 Wochen

    Linz, Oberösterreich, Österreich Proclinical Vollzeit

    Proclinical is currently assisting a Medical Technology client based in Linz, Austria in the search for a Business Systems Manager to join their Business Applications team. The ideal candidate will have the opportunity to play a key role in improving business and manufacturing processes. This position calls for a proactive individual who can manage system...

  • Quality Assurance Representative M/w/d

    vor 1 Woche

    Linz, Oberösterreich, Österreich Thermo Fisher Scientific Vollzeit

    Customers globally rely on our extensive range of products and services—from life-saving medicines to lab essentials to next-generation instruments. Our Operations team leverages our PPI (Practical Process Improvement Business System) to manufacture and produce these products and continuously improve productivity and quality all while contributing to our...

  • Maintenance Manager

    vor 1 Woche

    Linz, Oberösterreich, Österreich GlobeAir Vollzeit

    Company DescriptionBe part of our continuing growth storyGlobeAir is Europe's leading private jet charter offering on-demand flights at affordable rates.We are looking for talented passionate people with the ability to hit the ground running and achieve results. People who work at GlobeAir have an international background, are flexible and thrive in a...

  • Maintenance Manager

    vor 1 Woche

    Linz, Oberösterreich, Österreich GlobeAir AG Vollzeit

    Job description:Our Maintenance is headquartered in Linz-Hörsching, Austria (LOWL/LNZ) and is under supervision of Austrian CAA Austrocontrol.In this position you are responsible for the management and the execution of the maintenance of our fleet of 20 Mustang Cessna C510 including staff, stores, tools and technical record. You lead an international...

  • Business Systems Manager

    vor 1 Woche

    Linz, Oberösterreich, Österreich Corza Medical Vollzeit

    Vacancy Name Business Systems ManagerLocation of Work Linz, AustriaEmployment Type Full Time EmployeeOur missionAt Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between...

  • Business Systems Manager

    vor 1 Woche

    Linz, Oberösterreich, Österreich Corza Medical Vollzeit

    At Corza Medical, our mission is to support surgical providers with remarkable service, trusted performance, and outstanding value by creating an unmatched experience that stems from listening to the surgical experts themselves.Our product family is the result of years of experience championing surgeons and listening to their expertise. We deliver unmatched...

  • SekretärIn für den Vorstand der Universitätsklinik Innere Medizin 4 Pneumologie und Infektiologie

    vor 1 Woche

    Linz, Oberösterreich, Österreich Kepler Universitätsklinikum Vollzeit

    Responsibilities: General administrative tasks at a university office including correspondence Coordination of appointments and travel arrangements Patient management (scheduling appointments, providing telephone information, sending reports, invoicing) Organization of trainings and events Coordination of contracts, signatures, meetings, teleconferences,...

  • Vertriebsmitarbeiter Im Außendienst

    vor 1 Woche

    Linz, Oberösterreich, Österreich ELA Container GmbH Vollzeit

    Standort: LinzArbeitszeit: Vollzeit1.200 Mitarbeiter. 21 Standorte weltweit Container im Umlauf. Seit der Gründung im Jahr 1972 befinden wir uns stetig auf Wachstumskurs. Wir sind Spezialisten für mobile Raumlösungen in Containerbauweise. Unser familiengeführtes Unternehmen wächst dynamisch, daher suchen wir weltweit stetig qualifizierte, freundliche...

  • Director of Legal

    vor 1 Woche

    Linz, Oberösterreich, Österreich LAT Nitrogen Austria GmbH Vollzeit

    Location: Flexible locationApplication deadline: 31 March 2024Hours: Full-timeDuration: PermanentRole Purpose:As the Director of Legal, you will report directly to the Chief Executive Officer and be responsible for providing accurate, independent, and timely legal advice on various business issues. Your primary focus will be on managing legal risks, ensuring...

  • Technical Project Manager

    vor 1 Woche

    Linz, Oberösterreich, Österreich Tractive GmbH Vollzeit

    About usWe're the world's most-trusted name in keeping cats and dogs safe and healthy. The secret to that success? A team of truly unique individuals who care about each other just as much as going the extra mile for pet parents.Your territoryAs part of our Hardware team, you will:Make sure that our awesome trackers have the right certifications so that pet...