Regulatory Affairs Manager(Medical Devices)

Qualifications: 
> 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 extensive professional experience (6-10 years) in regulatory affairs for: 
*Medical Devices (preferably radiology products eg MR, CT)  
*SaMD, SaaS, and/or cloud deployments 
> 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, IEC 62570, IEC 60601(60601-2-33 would be an added advantage) 
> Experience in process or quality management would be an advantage 
Your Attributes And Skills:  
> You are business-fluent in English, enabling you to operate successfully in our international context; knowledge of German would be an advantage 
> Your personal qualities include a professional approach, skills in planning and organization, and cross-cultural experience 
> You also have team and communication skills, initiative, and a structured, target-oriented way of working 
> You champion the success of Siemens Healthineers with drive and passion 
Roles and Responsibilities: 
> Ensure the medical device products comply with the regulations of the regions where it is planned to be marketed and sold. 
> Maintaining a good understanding of new and existing regulations, standards and guidances that may impact their organization’s products and processes. 
> Collect, collate and evaluate product specific information in order to create and update the dossiers that must be submitted for new product licenses and license renewals. 
> Prepare submissions for regulatory registration and renewals 
> Maintaining data and files on country registrations for future reference, particularly in the event of an audit by a regulatory agency 
> Preparing for and supporting internal, regulatory, and third-party audits as necessary 
> Collaborate with the project teams and explaining regulatory requirements, procedures, and policies to all employees and stakeholders as necessary. 
> Able to work in cross functional teams with good communication & interpersonal skills