• RAQA SPECIALIST Jobs in Dubai - 3426033

  • 2 - 3 Years
  • Dubai (Dubai)
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Job Description

The Regulatory Affairs & Quality Assurance (RAQA) Specialist is responsible to interface with key members of the Quality organisation and assist in implementation of regulatory strategies as defined by MEA business team and communicated through EMEA central regulatory group

Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization Collects all materials required in submissions, license renewal, and annual registrations Keeps abreast of regulatory procedures and changes May interact with regulatory agencies Works on problems of complex scope where data analysis requires evaluation of specific factors Utilizes independent judgment within broad parameters to determine an appropriate solution May determine methods and procedures on new projects and may provide guidance to other lower-level staff

Key Activities & Accountabilities

Obtain product registration dossiers from EMEA Central RA and tailor them to meet country registration requirements
Develop close collaboration and communication with central RA groups in EEMEA to ensure timely execution of the MEA RA plan
Communicate with Stryker consultants and distributors across MEA to track and ensure timely dossier submission to the relevant authority
Assist Stryker Customer Service team and local dealers in preparing country specific regulatory documentation for custom clearance in MEA region
Create and maintain registration database for MEA countries
Responsible for the local demo process including ordering & maintenance of Stryker MEA demo inventory
Ensure complete trace-ability and storage of the products according to the ISO134852016 standard
Intermittently support ISO134852016 implementation project
Support in preparation and execution of yearly internal and external audits


A minimum of a BS degree in scienceengineering, or related field and at least 2-3 years experience in an international organizational business environment


Quality-focused experience within medical device industry
Prior experience of product registration of Medical device in MEA is preferred
Any experience in a MD area (also operational environment, good understanding of MD business and processes)
Experience in International Standards in particular ISO13485 is desirable
Proficiency in English
Strong project management skills
High ethical standards and integrity
Excellent interpersonal relationship building skills
Process consciousness
Good analytical and problem-solving skills
Action oriented, achiever, result driven
Good communication skills
Business orientated

Work From Home Not available

Travel Percentage 10 PERCENT

Profile Summary

Type:Company Job


Industry:Manufacturing/Industrial, Healthcare

Salary:As per Industry Standards

Function:Engg. project Mgmt./site Engg./Civil Engg.

Deadline:01st Feb 2025

Company Profile

Industry Healthcare (Medical Equipments & Supplies)