(Junior) Regulatory Affairs Manager (m/w/d) for AI-based Medical Software Products

Job description

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  (Junior) Regulatory Affairs Manager (m/w/d) for AI-based Medical Software Products to ensure market approval for our digital health products.

Your tasks and responsibilities:

·  You will develop regulatory strategies for product development and modifications to achieve clearance/approval in EU, US and internationally
·  You will serve as the Regulatory representative in project development teams to ensure timely market access of new products. Therefor you work globally close together with our Digital Health and regional departments
·  You will assess product, implementation and labelling changes for regulatory reporting impact and compliance to regulations
·  You will be responsible for the compilation and maintenance of international regulatory filings (including technical documentation for CE mark and 510(k) pre-market notifications) and gathering of data and the submission of registration documents to in-country Siemens Regulatory Representatives
·  You will maintain approvals/licenses/authorizations for existing marketing authorizations
·  You will provide support for audits and inspections by external bodies
·  You will stay current on global regulatory requirements, with focus on Software as a Medical Device

To find out more about the specific business, have a look at  https://www.siemens-healthineers.com/digital-health-solutions/digital-solutions-overview

Your qualifications and experience:

·  You have successfully completed a course of studies in a technical or clinical field, preferably in engineering, medicine, medical engineering or (medical) informatics
·  You can offer many years of professional experience in regulatory affairs for Medical Devices, ideally in the software area
·  You have a sound knowledge of international laws, standards and regulations for licensing medical devices, and of the business processes of medical device manufacturers (e.g. MDD & MDR, 21CFR 820; ISO 13485; IEC 62304; IEC 62366; ISO 14971)
·  Ideally you have knowledge of clinical processes and clinical decision support systems
·  Experience with Agile software development, continuous delivery, SaaS, and/or Cloud deployments are desirable
·  A knowledge of regulatory requirements for the clinical evaluation of software for medical devices is preferred
·  Experience in process or quality management would be an advantage

Your attributes and skills:

·  With your negotiable knowledge of English, you can understand technical documentation (product specifications, risk analyzes, etc.) and derive content for approval documents from it
·  With your excellent communication, network and moderation skills, you can communicate securely with the internal interfaces and externally with government officials
·  You are characterized by an analytical mindset, a strong focus on results, initiative, and the ability to understand complex technical and procedural relationships
·  Your personal qualities include a professional approach, team skills, planning and organization skills, and cross-cultural experience 

Our global team:

Siemens Healthineers is a leading global medical technology company. 50,000 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 Larah Joyce Stephan.

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.

Organization: Siemens Healthineers

Company: Siemens Healthcare GmbH

Experience Level: Early Professional

Job Type: Full-time