Regulatory Affairs Manager*in (f/m/d) for Software as Medical Device

Farkas Kiss Endre legjobb állása Siemens Healthineers

ulrich.kuenzel@siemens-healthineers.com;kathrin.palder@siemens-healthineers.com;sebastian.weiss@siemens-healthineers.com;marc.koebernick@siemens-healthineers.com;efsun.sarac@siemens-healthineers.com;kimberly.nissen@siemens-healthineers.com;julia.donhauser-bach@siemens-healthineers.com;gill.griffith-jones@siemens-healthineers.com;carlo.beck@siemens-healthineers.com;bailey.allen@siemens-healthineers.com;georgina.prodhan@siemens-healthineers.com;kristina.kilian@siemens-healthineers.com;stefanie.haug@siemens-healthineers.com;press.team@siemens-healthineers.com;hans-christian.jessen@siemens-healthineers.com;jeffrey.t.bell@siemens-healthineers.com;julie.gibson@siemens-healthineers.com;tina.grub@siemens-healthineers.com;heiko.jahr@siemens-healthineers.com;charissa.ikan-reyes@varian.com

Bewerbung fur Senior Developer (f/m/d) for Shui, the Design System of Siemens Healthineers

Levél szövege

Lieber Siemens Healthineers!

Ich möchte mich bei Ihrem Unternehmen als Regulatory Affairs Manager*in (f/m/d) for Software as Medical Device bewerben. 
Ich bin ein Fullstack-Entwickler, bei dem ich meine 10-jährige Erfahrung mit verschiedenen Technologien einsetzen kann.

Ich habe meinen Lebenslauf an diese E-Mail angehängt.

Wir freuen uns darauf, von Ihnen zu hören!


Endre Farkas Kiss "Sodika"
Java and PHP Fullstack Developer, Nudist, Vlogger

https://www.linkedin.com/in/farkas-kiss-63bb9210a
https://sodika.org

Álláshirdetés szövege

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?

Then come and join our global team as Regulatory Affairs Manager (f/m/d) for Software as Medical Device to help shape the regulatory approval strategy for software medical devices at D&A.
Choose the best place for your work – Within the scope of this position, it is possible, in consultation with your manager, to work mobile (within Germany) up to an average volume of 60% of the respective working hours.

This position is full-time or part-time with a minimum of 17,5h/week.

Your tasks and responsibilities:

You will analyze and interpret international laws, regulations and standards for medical device manufacturers and independently derive the resulting regulatory requirements for D&A products
You independently clarify worldwide regulatory requirements and develop the regulatory strategy for new products and new product versions. To this end, you will support employees at all levels with regard to legal compliance as a prerequisite for legal market access worldwide
You will work closely with the international departments at D&A and the regional Healthineers companies to coordinate regulatory activities and manage cross-business line regulatory activities
You coordinate regulatory approvals of D&A software worldwide, especially for China and the USA - and compile the required documentation for this purpose. In case of critical issues, you will independently conduct negotiations with authorities and other external institutions
You will participate in Healthineers-wide technical teams to achieve coordinated, application-appropriate implementations of country requirements for the business areas
You can learn more about this business area under Imaging IT

To find out more about the specific business, have a look at Imaging IT.

Your qualifications and experience:

You have a degree in the field of medicine, medical technology, (technical) communication, law, natural sciences or comparable
You have many years of professional experience in quality management or process management in the medical technology or pharmaceutical environment
You can demonstrate very good knowledge of standards (ISO13485, ISO14971) and legal requirements (e.g. German MPG, EU MDR/IVDR, Canadian MDR, US FDA), in particular with regard to qualification and classification of products
You have good knowledge of radiological systems and also of their software applications
Ideally, you are already very familiar with the approval of AI-based medical devices

Your attributes and skills:

With your English skills you can understand technical documentation (product specifications, risk analyses, etc.) and derive content for regulatory documents from it, German language skills are an additional plus
With your excellent communication, networking and moderation skills, you can communicate confidently with internal interfaces as well as externally with representatives of the authorities.
Personally, you are characterized by an analytical way of thinking, a strong focus on results, very good assertiveness, initiative and the ability to understand complex technical and process-related contexts

Our global team:
Siemens Healthineers is a leading global medical technology company. 69,500 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

Our culture:
Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.

Check our Careers Site at https://www.siemens-healthineers.com/de/careers
As an equal opportunity employer, we welcome applications from individuals with disabilities.

Wish to find out more before applying? Contact us: +49 (9131) / 17 – 1717, if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is
Katharina Tostmann.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started.

Siemens Healthineers Germany was awarded the Great Place to Work® certificate.