Back

Regulatory Affairs Specialist 2

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 Specialist 2       

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Regulatory Affairs Specialist 2, you will be responsible for:

  • You will create and implement strategies to support Siemens RU worldwide including Asia-Pacific, Middle East Asia, South and Latin America and Europe in registering Atellica Solutions and ADVIA Centaur products.
  • You will provide answers to technical questions from international regulatory authorities.
  • You will prepare and provide technical documents (test reports).   
  • You will lead projects related to new product registrations, license renewals, and re-registration requests via TeamSpace.
  • You will lead projects related to new product registrations, license renewals, and re-registration requests using RAPID database.
  • You liaise with RA core team and design change team members to support product registrations worldwide.
  • Various interdepartmental communications with marketing, manufacturing, R&D, OEMs, labeling, and others to support an efficient and effective international product registration process.

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

  • You interact with other international RA colleagues to establish best practices. 
  • You possess effective interdepartmental communications.
  • You can organize and send international regulatory submission dossiers.

Required skills to have for the success of this role

  • Bachelor’s degree in a scientific discipline with relevant experience or advanced degree in related field.
  • 4+ yrs of regulatory affairs experience
  • Knowledge and experience with global registrations of IVDs
  • Travel <5%
  • Good technical writing skills
  • Ability to read and interpret technical reports
  • Knowledge of regulatory requirements worldwide
  • Creative and adept at problem solving
  • Effective communication skills
  • Focus and attention to detail
  • Able to multi-task and work effectively in a dynamic environment
  • Skilled in Outlook, Adobe Acrobat, and Microsoft Office applications
  • Ability to work independently
  • Experience in a laboratory environment
  • Experience with immunoassays

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 Healthcare Diagnostics 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.

California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here.

Can't find what you are looking for?

Let's stay connected

Can't find what you are looking for?