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Regulatory Affairs Specialist

Job Description

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Job Posting Structure

Now’s our time to inspire the future of healthcare together.

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably.  A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.

Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence, they need to meet the clinical, operational and financial challenges of a changing healthcare landscape. Join our team now at Siemens Healthineers as a Regulatory Professional.

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

  • In your activities you will monitor global mailboxes and perform transactions in SAP to update shipping exclusions and quoting restrictions for commercial products for Siemens Laboratory Diagnostics (LD) Division
  • You will provide centralized support to LD QT RA specialists on the project teams to perform RA roles in Material Data Governance (MDG) tool and/or in SAP P41 and MDG-P61.
  • You will provide centralized support to the LD business for FDA UDI data maintenance and GUDID submissions.  
  • You will provide RA support for import/export issues for LD products as related to SAP P41.
  • You will have the opportunity to work directly with Regional Unit Regulatory Affairs Teams in various countries to ensure product control and compliance.
  • You will be involved with RA support of Internal/External audits as it relates to SAP P41 for control of product.
  • You will provide training in SAP P41 and MDG P61 to LD/QT/RA Specialists as needed.

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

  • You will demonstrate and apply knowledge of SAP, MDG, Quadrate and other computer skills such as Microsoft Word, Excel, Adobe Acrobat etc.
  • are preferred.
  • You will coordinate cross-functional efforts to collect information needed to complete SAP transactions in timely manner.
  • You will work cooperatively with internal and external customers to provide RA support
  • You may be required to perform ad hoc data mining requests from SAP P41 to obtain information not readily available in the standard SAP P41 reporting functions.  

Required skills to have for the success of this role

  • Bachelor’s degree or equivalent experience required
  • Minimum of 3 – 5 years SAP and Microsoft Excel experience required

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date except where prohibited by state law.

(Note: Accommodations may be requested for certain medical or religious reasons)

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: Mid-level 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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