QA/RA Associate

؜ - ؜الرياض ؜ -

تفاصيل الوظيفة

Job Summary

The Quality and Regulatory Affairs Associate is responsible of the product
registration in different markets in accordance with the local legal
requirements. He is also the main contact between the organization and
authorities to ensure reliable forward of information.


Principal Duties and Responsibilities


  • Support implementation, development, maintenance and control of a quality management system according to international standards and corporate guidelines/policies/procedures

  • Manage customer complaints handling and instructed actions e.g. product blockings, recalls, provide field safety notices, etc. Product enquiries on own responsibility via SAP system are essential required

  • Responsibility for product registration on the market in accordance with local legal requirements; main contact for the local competent authority and responsibility for the maintenance of the business in the local market

  • Assure an effective, consistent and reliable forward of information in terms of product surveillance on the local market in accordance with legal requirements and Zimmer procedures

  • Surveillance and forward of information concerning changes and/or new upcoming local legal requirements to assure the continuity of Zimmer's business

  • Support the internal and external audits; also within an internal auditor team coordinated by headquarters (if applicable)

  • Continuous communication with QA/RA EMEA

  • Support other Zimmer distribution organizations with regards to QA/RA requirements (e.g. product registrations)

  • Involvement in special projects and special duties like (re-)validation of technical systems and procedures


Expected Areas of Competence

Special expertise
* Microsoft Excel
* SAP
* Knowledge of ISO ‎9001, ISO ‎13485 and Medical Device Directive is a plus
* Knowledge of national medical device regulations
Languages
* Fluency in English and Arabic, both spoken & written.
* French is a plus
* Personal skills requirements
* Solid problem solving skills
* Ability to work independently and under pressure
* Organizational, follow up and time management skills


Education/Experience Requirements

Education
* Bachelor's Degree in Engineering, Business or Political Science.
Professional experience
* ‎1 to ‎3 years of experience in registration activities and/or quality assurance with preference to international medical device regulations.


Travel Requirements


  • ‎5%


Location

Riyadh or remote working

ملخص الوظيفة

  • المُعلن : Zimmer Biomet
  • تاريخ الإعلان : 06/05/2022
  • نوع العمل : -
  • مستوى الخبرة : -
  • المستوى التعليمي : -
  • مكان العمل : الرياض
  • الراتب : -
  • الهاتف : -

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