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Regulatory Affairs Professional

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 Regulatory Affairs Professional.

 

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Regulatory Affairs Professional you will be responsible for:

  • Provides regulatory information and guidance for product development and planning throughout the product lifecycle
  • Regulatory planning for new product introductions and product changes and assist in maintaining regulatory compliance
  • Plans and prepares product related medical device submissions with Siemens internal or external organizations according to regulatory requirements
  • Submits required documentation/information to local authorities or Siemens internal
  • Advises project steering groups on regulatory strategy and requirements for specific new products/solution
  • Identifies potential regulatory approval risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project
  • Identifies, analyzes and implements country specific requirements necessary for product related submission
  • Plans and prepares product related ultrasound medical device submissions
  • Performs review of promotional material and products being introduced into a market for regulatory compliance according to country specific requirements

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers

  • Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR
  • Experience with AI Software as Medical Devices, and Ultrasound Imaging Devices is preferred
  • Moderate to expert knowledge of diagnostic ultrasound and its clinical usefulness;
  • Superior presentation skills when communicating with all levels of the organization, business partners, and external sources.

Required skills to have for the success of this role

  • 8+ years of regulatory experience in medical tech industry
  • BS/MS degree or equivalent experience. Related engineering, science, regulatory or medical disciplines preferred
  • Strong organizational, negotiating, and problem-solving skills 
  • Excellent written and oral English communication skills; demonstrated public speaking skills
  • Ability to work independently in fast-paced environment and adapt to change
  • Willing to travel up to 10%

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.




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.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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