Consultant - Regulatory Affairs / Quality Assurance

Tokyo Permanent ¥6,000,000 - ¥8,000,000 Foreign Multinational
  • Contribute to Approval of New Medical Devices Globally
  • Work for a Specialized GxP Consulting Firm

About Our Client

  • GxP specialized company and full service quality solution provider across GCP, GLP, GMP & GDP in the Life Science Industry.
  • Worldwide clients from offices in Italy, Spain, Switzerland, Germany, LATAM, USA, the Middle East, China, India and Japan.

Job Description

  • Support implementation of MDR 2017/745 and IVDR 2017/746 requirements
  • Support projects for Medical Device EU and extra EU registration
  • Support Compliance and Quality Management System projects for Medical Device Companies
  • Perform audits in Medical Device area

The Successful Applicant

  • Degree in technical area
  • Strong English language proficiency
  • 3 or more years in regulatory affairs and quality assurance areas
  • Familiarity with MDR, including ISO 13485, MDD 93/42, 21 CFR part 820, new MDR 2017/745-746

What's on Offer

  • Opportunity to contribute to approvals of new devices globally
  • Participate in CE mark registration in EU
  • Work in a truly global organization
Contact
Ed Marsden
Quote job ref
4204873
Phone number
+813 6832 8981

Job summary

Function
Specialisation
Location
Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
4204873
Company Type