Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Project Leader - Essen - Discover International
-
Leitung Regulatory Affairs
vor 3 Monaten
Essen, Deutschland CUREosity GmbH VollzeitDüsseldorf Part Time - Deine Aufgaben: - Im Bereich **Regulatory Affairs** und **Qualitätsmanagement** verantwortest du die Qualität, Sicherheit und regulatorische Konformität unseres Medizintechnikproduktes auf der Grundlage eines ISO 13485-zertifiziertenQM-Systems. - Du bist die treibende Kraft für Regulatory Compliance von Medizinprodukten der...
-
Regulatory Affairs Specialist
vor 2 Wochen
Essen, Nordrhein-Westfalen, Deutschland Pharmiweb VollzeitJob DescriptionPharmiweb is seeking a highly skilled and motivated Clinical Trial Operations Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for ensuring the smooth execution of clinical trials from start to finish.Key Responsibilities:Study Management: Oversee the planning, execution, and closure of...
-
Environmental Project Leader
vor 1 Monat
Essen, Nordrhein-Westfalen, Deutschland Arcadis VollzeitPosition Title: Environmental Project Leader / Senior Consultant for industrial compliance processesLocations: Various locations across GermanyArcadis stands as a premier global consultancy firm dedicated to enhancing both natural and built environments. With a workforce exceeding 36,000 across 70 nations, we are focused on elevating the quality of life....
-
Environmental Project Leader
vor 1 Woche
Essen, Nordrhein-Westfalen, Deutschland Arcadis VollzeitPosition Title: Environmental Project Leader / Senior Consultant for industrial compliance processesLocations: Various locations across GermanyArcadis stands as a premier global consultancy firm dedicated to enhancing both natural and built environments. With a workforce exceeding 36,000 across 70 nations, we are focused on elevating the quality of life....
-
Compliance Specialist for Regulatory Affairs
vor 1 Monat
Essen, Nordrhein-Westfalen, Deutschland Roborock VollzeitPosition OverviewThe Regulatory Affairs Specialist will play a crucial role in ensuring that Roborock's operations in Europe adhere to legal standards and regulations. This position involves providing expert legal advice and compliance strategies to mitigate risks associated with business activities.Key Responsibilities1. Offer legal compliance guidance for...
-
Public Affairs Specialist
vor 1 Woche
Essen, Nordrhein-Westfalen, Deutschland HORIZONTjobs VollzeitPOSITION SUMMARY:The Public Affairs Specialist will be pivotal in managing and influencing the political landscape relevant to our organization. This role encompasses a variety of responsibilities aimed at enhancing our political engagement and advocacy efforts.Key Responsibilities:Conduct thorough analysis and evaluation of significant political topics and...
-
Public Affairs Specialist
vor 1 Monat
Essen, Nordrhein-Westfalen, Deutschland HORIZONTjobs VollzeitPOSITION SUMMARY:The Public Affairs Specialist will be pivotal in managing and influencing the political landscape relevant to our organization. This role encompasses a variety of responsibilities aimed at enhancing our political engagement and advocacy efforts.Key Responsibilities:Conduct thorough analysis and evaluation of significant political topics and...
-
Project Manager for Pipeline Projects
vor 2 Wochen
Essen, Nordrhein-Westfalen, Deutschland ARCADIS Germany Vollzeit**About the Role**We are seeking a highly skilled Project Manager to lead our pipeline projects at ARCADIS Germany. As a key member of our Resilience division, you will play a crucial role in protecting our environment and water resources by helping communities and businesses become more resilient to climate change and natural disasters.**Key...
-
Regulatory Frameworks Manager
vor 4 Wochen
Essen, Nordrhein-Westfalen, Deutschland E Hydrogen GmbH VollzeitCompany Overview:E.ON Hydrogen GmbH is a key player in the energy sector, focusing on the development of green gas solutions. As part of E.ON, a prominent international energy provider, we are dedicated to advancing a sustainable energy future.Role Overview:We are seeking a Manager of Regulatory Frameworks to oversee and enhance our regulatory strategies...
-
Regulatory Frameworks Manager
vor 4 Wochen
Essen, Nordrhein-Westfalen, Deutschland E Hydrogen GmbH VollzeitPosition Overview:E.ON Hydrogen GmbH is seeking a dedicated professional for the role of Manager Regulatory Frameworks. This position is pivotal in advancing our mission to lead in the green gas sector.About E.ON:E.ON is a prominent international energy provider, committed to enhancing energy networks and delivering innovative customer solutions. With a...
-
Associate Director Medical Affairs, EMEA
vor 3 Monaten
Essen, Deutschland Barrington James VollzeitBarrington James Board & Executive Partners are collaborating with a dynamic oncology biotech who are paving a new way for oncology treatments. They pride themselves in developing innovative products to improve patient outcomes and contribute to the advancement of cancer care. With a commitment to excellence and innovation, we are seeking a dynamic Associate...
-
Public Affairs Specialist
vor 1 Woche
Essen, Nordrhein-Westfalen, Deutschland HORIZONTjobs VollzeitPOSITION SUMMARY:As a Public Affairs Specialist, you will be instrumental in navigating the complex landscape of political engagement and advocacy. Your role will encompass a variety of responsibilities aimed at enhancing the company's influence and presence in public policy discussions.Key Responsibilities:Conduct thorough analysis and evaluation of...
-
Public Affairs Specialist
vor 1 Monat
Essen, Nordrhein-Westfalen, Deutschland HORIZONTjobs VollzeitPOSITION SUMMARY:As a Public Affairs Specialist, you will be instrumental in navigating the complex landscape of political engagement and advocacy. Your role will encompass a variety of responsibilities aimed at enhancing the company's influence and presence in public policy discussions.Key Responsibilities:Conduct thorough analysis and evaluation of...
-
Regulatory Manager
Vor 6 Tagen
Essen, Nordrhein-Westfalen, Deutschland E Hydrogen GmbH VollzeitAbout E.ON Hydrogen GmbHE.ON Hydrogen GmbH is a leading international investor-owned energy company, specializing in energy networks and customer solutions. With a global presence and a team of over 78,000 employees, we develop and sell innovative products and solutions for private, commercial, and industrial customers.Job SummaryWe are seeking a highly...
-
Regulatory Manager
Vor 6 Tagen
Essen, Nordrhein-Westfalen, Deutschland E Hydrogen GmbH VollzeitAbout E.ON Hydrogen GmbHE.ON Hydrogen GmbH is a leading international investor-owned energy company, specializing in energy networks and customer solutions. With a global presence and a team of over 78,000 employees, we develop and sell innovative products and solutions for private, commercial, and industrial customers.Job SummaryWe are seeking a highly...
-
Project Leader
vor 3 Monaten
Essen, Deutschland Hartmann VollzeitWe focus on **Senior Expert IT Advisory. And our approach is different.** We are convinced that to be the best partners and advisors for our clients it takes a rare combination**:Advisory experience** and training at the best strategy consulting firms and **significant leadership experience** in a line management role. Our projects are among the most...
-
Public Affairs Specialist
Vor 3 Tagen
Essen, Nordrhein-Westfalen, Deutschland HORIZONTjobs VollzeitAbout the Role:We are seeking a highly skilled Public Affairs Specialist to join our team at HORIZONTjobs. As a Public Affairs Specialist, you will be responsible for analyzing, evaluating, and politically accompanying relevant topics.Key Responsibilities:Analyze and evaluate political and economic developments and communicate them to stakeholdersEvaluate...
-
Public Affairs Specialist
Vor 3 Tagen
Essen, Nordrhein-Westfalen, Deutschland HORIZONTjobs VollzeitAbout the Role:We are seeking a highly skilled Public Affairs Specialist to join our team at HORIZONTjobs. As a Public Affairs Specialist, you will be responsible for analyzing, evaluating, and politically accompanying relevant topics.Key Responsibilities:Analyze and evaluate political and economic developments and communicate them to stakeholdersEvaluate...
-
Projektleiter:in - Lead Complex Projects
vor 2 Wochen
Essen, Nordrhein-Westfalen, Deutschland DMT VollzeitJob OverviewWe are seeking a highly skilled Projektleiter:in to lead complex projects and drive innovation and growth within our organization.Key ResponsibilitiesLead national and international complex projects, ensuring timely delivery and high-quality results.Collaborate with the project management team to develop and implement project steering.Responsible...
-
Projektleiter:in - Lead Complex Projects
vor 1 Woche
Essen, Nordrhein-Westfalen, Deutschland DMT VollzeitJob OverviewWe are seeking a highly skilled Projektleiter:in to lead complex projects and drive innovation and growth within our organization.Key ResponsibilitiesLead national and international complex projects, ensuring timely delivery and high-quality results.Collaborate with the project management team to develop and implement project steering.Responsible...
Regulatory Affairs Project Leader
vor 4 Monaten
We are currently supporting a leading provider of Quality/Regulatory consulting services in the medical device industry. The team of experts specialise in navigating complex regulatory landscapes to ensure compliance and market access for various medical device clients.
We are seeking a highly skilled Regulatory Affairs Project Leader to join the dynamic team. This role requires a strong understanding of global regulatory requirements, excellent project management skills, and the ability to collaborate effectively with cross-functional teams.
Responsibilities:
- Project Management: Lead and manage regulatory projects for clients from initiation to completion, ensuring adherence to project timelines and deliverables.
- Regulatory Strategy: Develop regulatory strategies tailored to each client's unique needs and product portfolio, including regulatory pathway selection, submission planning, and risk management.
- Regulatory Submissions: Prepare and review regulatory submissions, such as 510(k) premarket notifications, PMA applications, CE Marking applications, and other regulatory filings as required.
- Communication: Serve as the primary point of contact for clients on regulatory matters, providing regular updates and guidance on project status, regulatory changes, and potential risks.
- Cross-Functional Collaboration: Collaborate closely with internal teams, including R&D, Quality Assurance, Clinical Affairs, and Marketing, to ensure alignment on regulatory requirements and project objectives.
- Regulatory Intelligence: Stay abreast of changes in global regulatory requirements, guidance documents, and industry best practices to inform regulatory strategies and ensure compliance.
- Client Management: Build and maintain strong relationships with clients, understanding their business goals and providing strategic regulatory guidance to support their success.
Qualifications:
- Bachelor's degree in a scientific or technical discipline; advanced degree preferred.
- Minimum of 3 years of experience in regulatory affairs within the medical device industry, including experience with regulatory submissions and project management.
- Strong knowledge of global regulatory requirements, including FDA regulations (e.g., 21 CFR Part 820, Part 807), ISO 13485, and EU Medical Device Regulation (MDR).
- Proven track record of successfully managing regulatory projects and achieving regulatory approvals for medical devices.
- Excellent communication and interpersonal skills, with the ability to effectively interact with clients, regulatory agencies, and cross-functional teams.
- Detail-oriented with strong organizational and time management skills.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment.
Benefits:
- Competitive salary
- Comprehensive benefits package
- Opportunities for professional development and growth
- Collaborative and supportive work environment