Regulatory Affairs Specialist 4
Business Unit: Laboratory Diagnostics
Requisition Number: 233472
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%
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
- Maintains awareness of global regulatory legislation and assesses impact of changes to the business.
- Consults and provides training related to regulations and regulatory requirements.
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 4 – 6 years medical device/in vitro diagnostics regulatory and/or equivalent experience
- Experience with U.S. FDA submissions (Pre-Submissions, 510(k) and PMA) and interaction with FDA reviewers preferred
- Knowledge and experience with global registrations (including IVDR, Canada and Japan) 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