Regulatory Affairs Specialist
vor 3 Wochen
About Bruker
Bruker is a leading provider of innovative solutions for the life sciences and materials research industries. Our products and services enable researchers and scientists to advance their work and make groundbreaking discoveries.
Job Summary
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a Regulatory Affairs Specialist, you will be responsible for ensuring the regulatory compliance of our products, including in-vitro diagnostics, medical devices, and software.
Key Responsibilities
- Obtain worldwide approvals and registrations for in-vitro diagnostics, including EU and non-EU countries, as well as the USA.
- Implement conformity assessment procedures for CE marking and prepare and maintain technical documentation according to EU 2017/746, with a focus on Medical Device Software.
- Communicate with sales partners, authorities, and notified bodies to ensure regulatory conformity in target markets.
- Prepare regulatory documents, including regulatory reports, technical dossiers, and change notifications.
- Conduct regulatory assessments of changes and 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, but applications from graduates are also welcome.
- Knowledge of regulatory relevant standards, guidelines, and the IVD Regulation (EU) 2017/746.
- Ideal knowledge of software development processes according to IEC 62304, IEC 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 analytically, structured, precisely, and conscientiously.
About the Role
This is an exciting opportunity to join a dynamic team and contribute to the success of Bruker's innovative products. As a Regulatory Affairs Specialist, you will have the opportunity to work on a wide range of projects, from obtaining approvals and registrations to preparing regulatory documents and communicating with authorities and stakeholders.
What We Offer
Bruker offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a diverse and inclusive work environment that values and respects the contributions of all employees.
-
Regulatory Affairs Specialist
vor 4 Stunden
Bremen, Bremen, Deutschland Bruker VollzeitRegulatory Affairs SpecialistBruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a Regulatory Affairs Specialist, you will be responsible for ensuring the regulatory compliance of our products, including in-vitro diagnostics, in the EU and non-EU markets, including the USA.Key Responsibilities:Worldwide...
-
Regulatory Affairs Specialist
vor 4 Stunden
Bremen, Bremen, Deutschland Bruker VollzeitRegulatory Affairs SpecialistBruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a Regulatory Affairs Specialist, you will be responsible for ensuring the regulatory compliance of our products, including in-vitro diagnostics, in the EU and non-EU markets, including the USA.Key Responsibilities:Worldwide...
-
Regulatory Affairs Specialist
vor 3 Wochen
Bremen, Bremen, Deutschland Bruker VollzeitAbout BrukerBruker is a leading manufacturer of innovative analytical and scientific instruments for a wide range of industries, including life sciences, materials research, and pharmaceuticals.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a Regulatory Affairs Specialist, you will be...
-
Regulatory Affairs Specialist
vor 3 Wochen
Bremen, Bremen, Deutschland Bruker VollzeitAbout BrukerBruker is a leading manufacturer of innovative analytical and scientific instruments for a wide range of industries, including life sciences, materials research, and pharmaceuticals.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a Regulatory Affairs Specialist, you will be...
-
Regulatory Affairs Specialist
Vor 3 Tagen
Bremen, Bremen, Deutschland Bruker VollzeitAbout the RoleBruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a key member of our software development team, you will be responsible for ensuring the regulatory compliance of our products, particularly in the area of in-vitro diagnostics.Key ResponsibilitiesObtain worldwide approval and registration of...
-
Regulatory Affairs Specialist
Vor 3 Tagen
Bremen, Bremen, Deutschland Bruker VollzeitAbout the RoleBruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a key member of our software development team, you will be responsible for ensuring the regulatory compliance of our products, particularly in the area of in-vitro diagnostics.Key ResponsibilitiesObtain worldwide approval and registration of...
-
Regulatory Affairs Specialist
vor 1 Woche
Bremen, Bremen, Deutschland Primavera Life GmbH VollzeitDeine HerausforderungWir suchen einen erfahrenen Regulatory Affairs-Experten, der unsere Kosmetikprodukte auf die neuesten rechtlichen Anforderungen hin überprüft und sicherstellt, dass wir alle notwendigen Zertifikate und Genehmigungen haben.Deine AufgabenDie Anforderungen aus dem Kosmetikrecht, Gefahrstoffrecht, Gefahrgutrecht und anderen relevanten...
-
Regulatory Affairs Specialist
vor 1 Woche
Bremen, Bremen, Deutschland Primavera Life GmbH VollzeitDeine HerausforderungWir suchen einen erfahrenen Regulatory Affairs-Experten, der unsere Kosmetikprodukte auf die neuesten rechtlichen Anforderungen hin überprüft und sicherstellt, dass wir alle notwendigen Zertifikate und Genehmigungen haben.Deine AufgabenDie Anforderungen aus dem Kosmetikrecht, Gefahrstoffrecht, Gefahrgutrecht und anderen relevanten...
-
Regulatory Affairs Specialist
vor 1 Woche
Bremen, Bremen, Deutschland Bruker VollzeitAbout the RoleBruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a key member of our software development team, you will be responsible for ensuring the regulatory compliance of our products, particularly in the area of in-vitro diagnostics.Key ResponsibilitiesObtain worldwide approval and registration of...
-
Regulatory Affairs Specialist
vor 1 Woche
Bremen, Bremen, Deutschland Bruker VollzeitAbout the RoleBruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a key member of our software development team, you will be responsible for ensuring the regulatory compliance of our products, particularly in the area of in-vitro diagnostics.Key ResponsibilitiesObtain worldwide approval and registration of...
-
Regulatory Affairs Specialist
vor 3 Wochen
Bremen, Bremen, Deutschland Bruker VollzeitAbout BrukerBruker is a leading manufacturer of innovative analytical and scientific instruments for various industries, including life sciences and materials research.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a Regulatory Affairs Specialist, you will be responsible for ensuring the...
-
Regulatory Affairs Specialist
vor 3 Wochen
Bremen, Bremen, Deutschland Bruker VollzeitAbout BrukerBruker is a leading manufacturer of innovative analytical and scientific instruments for various industries, including life sciences and materials research.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a Regulatory Affairs Specialist, you will be responsible for ensuring the...
-
Regulatory Affairs Specialist
vor 2 Wochen
Bremen, Bremen, Deutschland Bruker VollzeitAbout the RoleBruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a key member of our software development team, you will be responsible for ensuring the regulatory compliance of our products, particularly in the area of in-vitro diagnostics.Key ResponsibilitiesObtain worldwide approval and registration of...
-
Regulatory Affairs Specialist
vor 2 Wochen
Bremen, Bremen, Deutschland Bruker VollzeitAbout the RoleBruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a key member of our software development team, you will be responsible for ensuring the regulatory compliance of our products, particularly in the area of in-vitro diagnostics.Key ResponsibilitiesObtain worldwide approval and registration of...
-
Payroll Specialist
vor 3 Wochen
Bremen, Bremen, Deutschland ADP VollzeitWe are seeking a highly skilled Payroll Specialist to join our team at ADP. As a Payroll Specialist, you will be responsible for managing payroll for a specific client base, coordinating data entry, and generating necessary documents.Key Responsibilities:Manage payroll for a specific client base, ensuring accuracy and compliance with regulatory...
-
Payroll Specialist
vor 3 Wochen
Bremen, Bremen, Deutschland ADP VollzeitWe are seeking a highly skilled Payroll Specialist to join our team at ADP. As a Payroll Specialist, you will be responsible for managing payroll for a specific client base, coordinating data entry, and generating necessary documents.Key Responsibilities:Manage payroll for a specific client base, ensuring accuracy and compliance with regulatory...
-
Frequency Coordination and Management Specialist
vor 3 Wochen
Bremen, Bremen, Deutschland OHB VollzeitJob SummaryOHB System AG, a leading European space company, is seeking a highly skilled Frequency Coordination and Management Specialist to enhance its position as a telecommunications systems provider. The successful candidate will be responsible for assessing filing status, devising optimal strategies for frequency coordination, and overseeing the filing...
-
Frequency Coordination and Management Specialist
vor 3 Wochen
Bremen, Bremen, Deutschland OHB VollzeitJob SummaryOHB System AG, a leading European space company, is seeking a highly skilled Frequency Coordination and Management Specialist to enhance its position as a telecommunications systems provider. The successful candidate will be responsible for assessing filing status, devising optimal strategies for frequency coordination, and overseeing the filing...
-
Frequency Coordination and Management Specialist
vor 3 Wochen
Bremen, Bremen, Deutschland OHB VollzeitJob SummaryOHB System AG, a leading European space company, is seeking a highly skilled Frequency Coordination and Management Specialist to enhance its position as a telecommunications systems provider. The successful candidate will be responsible for assessing filing status, devising optimal strategies for frequency coordination, and overseeing the filing...
-
Operational Procurement Specialist
vor 3 Wochen
Bremen, Bremen, Deutschland FERCHAU GmbH VollzeitWe are seeking a highly motivated and experienced professional to join our team at FERCHAU GmbH as an Operational Procurement Specialist. This role will be responsible for managing the procurement process, ensuring timely and cost-effective delivery of goods and services.Key Responsibilities:Develop and implement procurement strategies to meet business...
