Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Specialist - Bremen, Bremen - Bruker
-
Regulatory Affairs Specialist
vor 4 Wochen
Bremen, Bremen, Deutschland Bruker Daltonics GmbH & Co. KG VollzeitBruker Daltonics GmbH & Co. KG is seeking a highly skilled Regulatory Affairs Specialist to join their team in Bremen, Germany. As a key member of the regulatory team, you will be responsible for ensuring the compliance of our products with regulatory requirements.About the Role:The ideal candidate will have a strong background in regulatory affairs, with...
-
Regulatory Affairs Specialist
vor 1 Monat
Bremen, Bremen, Deutschland Bruker Daltonics GmbH & Co. KG VollzeitBe Part of Something InnovativeAt Bruker Daltonics GmbH & Co. KG, we're pushing the boundaries of microorganism identification. Our MALDI Biotyper is the standard in the industry, enabling microbiology laboratories to identify microbes reliably and rapidly. With applications in research, healthcare, and beyond, we're seeking a talented Regulatory Affairs...
-
Regulatory Affairs Specialist
vor 4 Wochen
Bremen, Bremen, Deutschland Bruker Daltonics GmbH & Co. KG VollzeitAs a Regulatory Affairs Specialist at Bruker Daltonics GmbH & Co. KG, you will play a crucial role in ensuring the regulatory compliance of our products. Our innovative MALDI Biotyper is a standard in microorganism identification, enabling microbiology laboratories to identify microbes reliably and rapidly. It is used worldwide in various application areas,...
-
Regulatory Affairs Specialist
vor 4 Wochen
Bremen, Bremen, Deutschland Bruker VollzeitOverviewBruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our products with regulatory requirements in the EU and non-EU markets, including the USA.Key ResponsibilitiesObtain worldwide approval and registration of...
-
Regulatory Affairs Specialist
vor 1 Monat
Bremen, Bremen, Deutschland Bruker Daltonics GmbH & Co. KG VollzeitAre you interested in a challenging role that combines regulatory expertise with a passion for innovation? At Bruker Daltonics GmbH & Co. KG, we are seeking a Regulatory Affairs Specialist to join our team.As a key member of our regulatory team, you will be responsible for ensuring the compliance of our products with regulatory requirements in the EU and...
-
Regulatory Affairs Specialist
vor 4 Wochen
Bremen, Bremen, Deutschland Bruker VollzeitOverviewBruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our products with regulatory requirements in the EU and non-EU markets, including the USA.Key ResponsibilitiesObtain worldwide approval and registration of...
-
Bremen, Bremen, Deutschland ACTEGA DS GmbH VollzeitÜberblickAls Regulatory Affairs Manager bei ACTEGA DS GmbH übernehmen Sie die strategische Führung der Bereiche Umwelt, Sicherheit und Chemikalienmanagement.Leitung der BereicheÜbernehmen Sie die proaktive Leitung der Bereiche Umwelt, Sicherheit und Chemikalienmanagement, einschließlich der Führung von 2...
-
Frequency Coordination Specialist
vor 4 Wochen
Bremen, Bremen, Deutschland OHB VollzeitOHB System AG is a leading European space company, part of the OHB SE high-tech group. With over 3,000 employees, we specialize in high-tech solutions for space, including low-orbiting and geostationary satellites for Earth observation, navigation, telecommunications, science, and space exploration.We are seeking a Frequency Coordination Specialist to...
-
Frequency Coordination and Management Specialist
vor 4 Wochen
Bremen, Bremen, Deutschland OHB VollzeitOHB System AG –OHB System AG is a leading European space company with a strong presence in Bremen and Oberpfaffenhofen near Munich. With over 40 years of experience, the company specializes in high-tech solutions for space, including low-orbiting and geostationary satellites for Earth observation, navigation, telecommunications, science, and space...
-
Frequency Coordination and Management Specialist
vor 4 Wochen
Bremen, Bremen, Deutschland OHB VollzeitOHB System AG is a leading space company in Europe, part of the listed high-tech group OHB SE. We are seeking a Frequency Coordination and Management Officer to enhance our position as a telecommunications systems provider.This role demands a high level of interdisciplinary collaboration with the payload technical team, project management, and business...
-
Regulatory Affairs Specialist
vor 2 Monaten
Bremen, Deutschland Bruker Daltonics GmbH & Co. KG VollzeitAre you interested to be part of something innovative? Join the Bruker regulatory team working on the MALDI Biotyper. Our product is the standard in microorganism identification that enables microbiology laboratories to identify microbes reliably and rapidly. It is used worldwide in many exciting application areas from new research groups to life saving...
-
Leitung EHS
vor 3 Wochen
Bremen, Deutschland ACTEGA DS GmbH VollzeitWe are ALTANA: eine Unternehmensgruppe – vier Geschäftsbereiche: BYK, ECKART, ELANTAS und ACTEGA. Global führend in Spezialchemie mit rund 7.000 Mitarbeiterinnen und Mitarbeitern, einem Umsatz von mehr als 3 Mrd. Euro und vielen Entfaltungsmöglichkeiten für Sie. Möchten Sie Ihr Leben um dieses entscheidende Plus bereichern? ACTEGA, als Teil der ALTANA...
-
Leitung EHS
vor 6 Monaten
Bremen, Deutschland Hays Vollzeit**Leitung EHS & Regulatory Affairs** (m/w/d) **Festanstellung durch unseren Kunden** **Bremen** **Startdatum: sofort** Referenznummer: 746850/1 **Bewerbung starten** **Ihre Aufgaben**: - Aktive Führung in den Bereichen Umwelt, Gesundheit, Sicherheit und Regulierung - Disziplinarische Führungsverantwortung - Gestaltung und Implementierung der...
-
Leitung EHS
vor 3 Wochen
Bremen, Deutschland ACTEGA DS GmbH Vollzeit**Leitung EHS & Regulatory Affairs**: **Standort: Bremen**: **Verantwortlichkeiten**: **Spannende Aufgaben erwarten Sie** - In dieser Rolle übernehmen Sie proaktiv die Leitung der Bereiche Environment, Health, Safety und Regulatory inklusive der Führung von 2 Mitarbeitenden. Sie gestalten die Nachhaltigkeitstransformation, sorgen für die Sicherstellung...
-
Regulatory Affairs Specialist
vor 4 Wochen
Bremen, Deutschland Bruker Daltonics GmbH & Co. KG VollzeitAre you interested to be part of something innovative? Join the Bruker regulatory team working on the MALDI Biotyper. Our product is the standard in microorganism identification that enables microbiology laboratories to identify microbes reliably and rapidly. It is used worldwide in many exciting application areas from new research groups to life saving...
-
Leitung EHS
vor 5 Monaten
Bremen, Deutschland ACTEGA DS GmbH Vollzeit**Leitung EHS & Regulatory Affairs (m/w/d)**: **Standort: Bremen**: **Verantwortlichkeiten**: **Spannende Aufgaben erwarten Sie** - In dieser Rolle übernehmen Sie proaktiv die Leitung der Bereiche Environment, Health, Safety und Regulatory inklusive der Führung von 2 Mitarbeitenden. Sie gestalten die Nachhaltigkeitstransformation, sorgen für die...
-
Qm Assistant
vor 5 Monaten
Bremen, Deutschland Digital Medicine VollzeitFraunhofer MEVIS is a globally renowned development center in the international research community for computer assistance in digital medicine. We pursue a patient-centered and clinical workflow-oriented approach to solving clinically relevant challenges in image - and data-based diagnosis and therapy. To provide real-world solutions in line with regulatory...
-
(Senior) Manager Strategic Projects
vor 2 Monaten
Bremen, Deutschland Bruker VollzeitÜberblick Bruker Corporation (NASDAQ: BRKR) is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker’s high performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and...
-
Regional C&b Lead
vor 2 Monaten
Bremen, Deutschland HITACHI ENERGY GERMANY AG Vollzeit**Description** “Compensation & Benefits function supports the business in attracting and retaining right talent in a competitive market environment. With overarching commitment to keep our “deal” competitive externally while ensuring we are consistent and equitable within the organization. We achieve this by providing specialist knowledge and...
-
Director & Senior Counsel Labor Relations (M/F/d)
vor 3 Monaten
Bremen, Deutschland Mondelēz International Vollzeit**Are You Ready to Make It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It Matter.** As the lead for legal activities for the company across the region, business units and sub-function areas in the country and/or across multiple countries, you identify business needs and design, develop and drive the...
-
Environmental Specialist
vor 2 Wochen
Magdeburg, Bremen, Aurich near Emden, Deutschland ENERCON VollzeitInnovative ideas are the hallmark of our successes and move us on. We are passionate about realizing wind energy projects across the globe and meeting tomorrow's energy technology challenges. You and your engagement can make a contribution to shape the future of renewable energies. ENERCON has been one of the technology leaders in the wind power sector for...
-
Director & Senior Counsel Labor Relations (m/f/d)
vor 3 Monaten
Bremen, Deutschland Mondelēz International VollzeitDescription Are You Ready to Make It Happen at Mondelēz International? Join our Mission to Lead the Future of Snacking. Make It Matter. As the lead for legal activities for the company across the region, business units and sub-function areas in the country and/or across multiple countries, you identify business needs and design, develop and...
Regulatory Affairs Specialist
vor 1 Monat
Overview
Bruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our products with regulatory requirements worldwide.
Key Responsibilities
- Obtain worldwide approval and registration of in-vitro diagnostics (EU and non-EU, including USA)
- Implement conformity assessment procedures for CE marking, prepare and maintain technical documentation according to EU 2017/746, with focus on Medical Device Software
- Communicate with sales partners, authorities, and notified bodies
- Ensure regulatory conformity in the respective target market
- Prepare regulatory documents, including regulatory reports, technical dossiers, and change notifications
- Regulatory assessments of changes
- Evaluate regulatory and normative changes
Requirements
- Degree in biology, natural sciences, medical technology, or comparable qualifications
- Relevant professional experience in regulatory affairs and/or quality management is an advantage, applications from graduates are also welcome
- Knowledge of regulatory relevant standards, guidelines, and the IVD Regulation (EU) 2017/746
- Ideal knowledge of software development process according to IEC 62304, IEC 81001-5-1, 82304, and cybersecurity requirements within the EU and USA
- Strong communication skills and technical expertise when working with internal and external interfaces
- Ability to work in an analytical, structured, precise, and conscientious manner
About Bruker
Bruker is a leading manufacturer of scientific instruments for research and industry. Our products are used in a wide range of applications, from materials science to life sciences. We are committed to innovation and excellence in all aspects of our business.
