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Regulatory Affairs Specialist 4

Job Description

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.

This Regulatory Affairs Specialist will assist in obtaining and maintaining government approval (US and worldwide) for Siemens products. This person will work on document preparation, information management, file maintenance, and coordination of tasks across multiple departments. Part of their strategic directive will be to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs.  Regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.

Some typical job tasks include:

a) Explain regulations, policies, or procedures
b) Maintain data in information systems or databases
c) Ensure compliance with regulations
d) Advise others on regulatory and compliance matters
e) Evaluate applicable laws and regulations to determine impact on company activities
f) Provide technical review of data or reports
g) Coordinate regulatory documentation activities
h) Identify and interpret relevant regulatory guidelines

Attention to detail is extremely important, as is the ability to adapt quickly to changing regulations. They must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees and team members to coordinate complex activities.

Academic requirements:
This professional must have a bachelor’s degree. Typical majors include biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, and engineering. Coursework in law, marketing, business, and statistics is also useful. Advanced degree or RAC credential is helpful. 

Experience with IVD medical devices is a plus.

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.

California Privacy Notice
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