Siemens Regulatory Affairs Specialist in Walpole, Massachusetts
Job Posting Structure
Now’s our time toinspire 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 ambitiousprofessional, looking for the next step in their career. As a RegulatoryProfessional, you will be responsible for:
In your activities you will monitor globalmailboxes and perform transactions in SAP to update shipping exclusions and quotingrestrictions for commercial products for Siemens Laboratory Diagnostics (LD)Division
You will provide centralized support to LD QT RAspecialists on the project teams to perform RA roles in Material DataGovernance (MDG) tool and/or in SAP P41 and MDG-P61.
You will provide centralized support to the LD businessfor FDA UDI data maintenance and GUDID submissions.
You will provide RA support for import/export issues forLD products as related to SAP P41.
You will have the opportunity to work directly withRegional Unit Regulatory Affairs Teams in various countries to ensure productcontrol and compliance.
You will be involved with RA support of Internal/Externalaudits as it relates to SAP P41 for control of product.
You will provide training in SAP P41 and MDG P61 to LD/QT/RASpecialists as needed.
This position maysuit you best if you are familiar with what is below, and would like to do develop your career withHealthineers
You will demonstrate and apply knowledge of SAP, MDG,Quadrate and other computer skills such as Microsoft Word, Excel, Adobe Acrobatetc.
You will coordinate cross-functional efforts tocollect information needed to complete SAP transactions in timely manner.
You will work cooperatively with internal and externalcustomers to provide RA support
You may be required to perform ad hoc data mining requestsfrom SAP P41 to obtain information not readily available in the standard SAPP41 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 experiencerequired
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 tojoin us in transforming the way healthcare is delivered, visit our career siteat 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.
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