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Director, Global Regulatory Affairs (Ultrasound)

Job Description

Now’s our time to inspire the future of healthcare together. 
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. 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. This is what truly matters to us.
 
Join our team now at Siemens Healthineers as Director of Global Regulatory Affairs within our Ultrasound Business Unit.

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Director of Global Regulatory Affairs, you will be responsible for: 
  • Combining scientific, regulatory and business expertise to enable devices that are developed, manufactured and distributed to meet required legislation.  
  • Providing global regulatory strategy and direction to achieve early device market access in support of business objectives for EU class IIa and III devices.
  • Developing and supervising a global team of regulatory professionals
  • Overseeing changing regulations and guidance, interfacing with outside regulatory agencies and trade associations and providing executive management with regulatory metrics/information.  
  • Identifying and presenting regulatory strategy risk mitigation options to decision makers  
  • Overseeing processes involved with maintaining annual licenses and registrations 
  • Review and approval of labeling to ensure compliance 
  • Influencing design processes to drive clinical claims development early in the development process. 
This position may suit you have the following: 
  • Moderate to expert knowledge of diagnostic ultrasound and its clinical utility 
  • Experience with sterile devices including GMP, GCP, sterilization, packaging,  and clean room environments. 
  • Superior presentation skills when communicating with all levels of the organization, business partners, and external sources.  
  • Global level influencing and are recognized as an expert resource both internally and externally.  
  • Providing effective leadership without direct authority.  
Required skills to have for the success of this role:
  • 8+ years of regulatory experience in medical devices and expertise with global medical device regulations and registration processes, especially USA, EU and China. 
  • BS/MS degree or equivalent experience. Related engineering, science, regulatory or medical/clinical disciplines preferred.  
  • Ability to manage multiple responsibilities with a high degree independence  
  • Strong organizational, negotiating, and problem-solving skills  
  • Excellent written and oral English communication skills; demonstrated public speaking skills 
  • Proven ability to interact successfully with all levels of the organization  
  • Willing to travel up to 20% 
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally. 

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.  

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.  

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

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Organization: Siemens Healthineers

Company: Siemens Medical Solutions USA, Inc.

Experience Level: Experienced Professional

Job Type: Full-time



Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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