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Regulatory Affairs Specialist II

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 a Regulatory Affairs Specialist II.

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

1.                Prepares regulatory documentation pertaining to International registrations for new products and for product design changes.

2.                Completes regulatory documentation for CE Marking according to IVDR for IVD medical devices (Technical Files, Declarations of Conformity etc.).

3.                Performs RA Assessments for design changes, such as but not limited to 510(k) Note-to-Files.

4.                Conducts review of product labeling and advertising/promotional material for regulatory compliance.

5.                Supporting project teams for new product development, compliance projects and design change

6.                Supports internal/external audits (such as FDA, Notified Body MDSAP/ISO 13485 inspections).

7.                May develop regulatory strategies and prepare regulatory filings for EU, US, Canada and global markets for special projects in development or significant design changes, where required.

This position may suit you best if you are proficient with the below skills and would like to develop your career with Healthineers:

1.                You have experience in writing regulatory submissions preferably US 510k, Health Canada License applications or EU Technical files

2.                You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)

3.                You have attention to detail, able to manage and track multiple requests at once

4.                You have experience leading projects and presenting to internal stakeholders

5.                You can utilize regulations and procedures to make decisions in regards to design change or other regulatory inputs

Experience and requirements for success in this role:

6.                Bachelor’s degree or equivalent experience is required

7.                Minimum of 2-5 years’ experience in Regulatory Affairs, preferably within the Medical Device industry.

8.                Must have strong oral and written communication skills

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.



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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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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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