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Japan

 

QA/RA Medical Device Consultant

Requested Languages:

English  Japanese
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job at pqe

PQE Group is a Contract Quality Organization and a Complete Quality Solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry. Since 1998, we have successfully completed more than 7,000 projects worldwide and now serve our Clients from offices in Italy, Spain, Switzerland, Germany, LATAM, USA, the Middle East, China, India and Japan. As an international group we have experience working in more than 25 languages and have an excellent history of supporting small, medium and large size companies exceeding compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA / GILS and other local authorities. PQE Group offers turnkey quality solutions and focuses on offering exceptional cost effectiveness, whilst maintaining highest quality standards for our Clients.

Due to a constant growth, we are looking for a QA/RA Medical Device Consultant.

The resource shall support Compliance projects in Medical Device area. The resource shall also bring new expertise in quality management and regulatory affairs for Medical Device and contribute to the growth of the Medical Device team and to enhance PQE services in Medical Device area.



    JOB TASKS
  • 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
    EDUCATION:
  • Degree in technical discipline
    SKILLS REQUIRED:
  • English language proficiency at least B2 Level
  • Willingness to travel up to 75%
  • Strong work ethic
  • Knowledge of Post market Surveillance and V&V requirements will be a plus

    KNOWLEDGE REQUIRED:
  • Medical Device requirements (ISO 13485, MDD 93/42, 21 CFR part 820, new MDR 2017/745-746 …)
  • EU and Extra EU MD registration processes
  • 510 (k) and PMA process
  • Risk Management for Medical Devices
    EXPERIENCE REQUIRED:
  • 3+ years in Quality Assurance and/or Regulatory Affairs, in Consultancy or Medical Device industry

Full-Time Job

If interested, please send your resume in English, clicking on "Apply Now" button on this page.
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.


job at pqe