Regulatory Affairs Specialist 3
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%
- 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.
- 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
- 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