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Danaher Koto-Ku, 日本 フルタイムAt Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved ...
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Danaher Koto City, 日本 フルタイムAt Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved ...
Senior Regulatory Affairs Specialist - Koto City, 日本 - Advanced Sterilization Products
2日前
説明
responsibilities
.§Related Regulatory and/or Quality Assurance experience.
Nice to Have:
5+ years medical device industry experience.
Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
New product development experience.
Application for approval (certification) orauthorization experience.
Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations :
(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)
·Proper application of Japan Pharmaceutical Affairs Law, QMS ordinances, and various other regulations.
·Proper application of Quality Management System Standard ISO 13485.
·Proper application of Risk Management Standard ISO 14971.
·Understanding of US and EU pharmaceutical regulations.
·Excellent written and oral communication skills.
·Good and analytical thinking, problem solving and investigative skills.
·Proficiency in Microsoft Office and all related applications.
