Senior Regulatory Affairs Specialist

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 writ...