Regulatory Affairs Specialist 3

Job Description

Organization: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 230950
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%

Division Description:

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.
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Job Description:

Specific Requirements: Position Overview
- Siemens’ Healthcare Sector is one of the world’s largest suppliers to the healthcare industry and a leader in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens Healthcare offers its customers products and solutions for the entire lifecycle of patient care – from prevention and early detection, to diagnosis, treatment, and aftercare.
- For this job, the successful candidate will develop and execute strategy for new product development and design changes for in vitro diagnostic products.

- Develops and executes regulatory strategy for assigned projects on multi-discipline teams and interacts with regulatory authorities.
- Preparation of Regulatory submissions (US and international) for in vitro diagnostic products
- Ensures compliance to US FDA Quality System Regulations and internal Quality System.
- Reviews and approves product labeling and advertising/promotional material.
- Participates in audits and inspections by regulatory authorities and certification/accreditation bodies.

Required Knowledge/Skills, Education, and Experience
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
- Minimum 2 – 4 years medical device/in vitro diagnostics regulatory or equivalent experience.
- Experience with U.S. FDA 510k submissions and interaction with FDA reviewers preferred.
- Knowledge and experience with global registrations and development of in vitro diagnostics and medical devices a plus.
- Strong leadership, interpersonal, communication and organizational skills required.
- Must possess a high level of critical and strategic thinking skills and be a detail oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities.
- Must be able to set priorities as well as adapt to changing priorities

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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, 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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