Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Specialist Medical Devices EMEA - Berlin, Berlin - 3M
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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vor 4 Wochen
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vor 4 Wochen
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vor 4 Wochen
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Regulatory Affairs Specialist
vor 4 Wochen
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Regulatory Affairs Specialist
vor 4 Wochen
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Regulatory Affairs Specialist
vor 3 Wochen
Berlin, Berlin, Deutschland GULP – experts united VollzeitWe are seeking a highly skilled Regulatory Affairs Manager to join our team at GULP – experts united. The ideal candidate will have a strong background in regulatory affairs and experience in the development and production of solutions for cancer treatment.Key Responsibilities:Creation and maintenance of documentation for the approval of...
Regulatory Affairs Specialist Medical Devices EMEA
vor 2 Monaten
Job Title: Regulatory Affairs Specialist Medical Devices EMEA
About the Role:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in the Medical Devices EMEA region. As a key member of our team, you will be responsible for providing regional certification and conformance in the testing, certification, and registration of personal protective equipment (PPE) that is registered as a medical device.
Key Responsibilities:
- Medical device registration in EMEA countries, including Middle East and Africa.
- Fulfilling requirements for roles required within applicable standards and regulations.
- Managing the EUDAMED database.
- Maintaining the compliance status of medical respirators.
- Regulatory/compliance input into PSD new product projects and conducting regulatory assessments for new products during the commercialization process.
- Overseeing the compliance aspect of product changes and making refiling/modification decisions for changes made to existing medical respirators.
- Working with cross-functional groups to ensure the registration files quality and on-time completion.
- Actively working with external parties to accelerate the registration processes.
- Monitoring and understanding registration-related regulations across EMEA and taking actions accordingly.
- Engaging with regulatory authorities with any post-market issues.
Requirements:
- Bachelor's degree or higher in a relevant field.
- Strong proficiency in both English and German.
- Fundamental working experience as a regulatory affairs professional in the medical device area.
- Working experience in multinational companies.
What We Offer:
3M offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to diversity and inclusion and seek to create a workplace that is welcoming and inclusive for all employees.
How to Apply:
If you are a motivated and experienced regulatory affairs professional looking for a new challenge, please submit your application, including your resume and a cover letter, to our career page. We look forward to hearing from you
