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Quality & Regulatory Coordinator

Apply now Job no: 608427
Work type: Permanent
Location: Dubai
Categories: Middle East & Africa, Individual Contributor, Business Analysis/Requirements, Quality & Regulatory

 

Duties and Responsibilities:

  • Manage compliance to the Cochlear LTD Quality Policy, Quality Manual, and Control of Documents Policy
  • Evaluate the local CME requirements for documentation of QMS records, and provide training and support to facilitate the use of QMS by all CME employees
  • Conduct quality checks for registered processes and documents, and identify corrective or preventive actions to improve compliance
  • Manage the Product Registration of all Cochlear products in the region, track the registration, store copies of certificates and trigger timely renewal of registration with the Distributor
  • Coordinate the required documents for submission and delivery of tenders, track the requirements and the status of document preparation
  • Ensure documents meet the specified requirements as per the tender file, as per signature, letterhead, legalization, and any other specified requirement
  • Track the status of agreements between Cochlear and Cochlear ME Distributors, and trigger renewal of agreements as required, including but not limited to Distribution Agreements, Target Settings, Annual Undertakings, Pricing Agreements
  • Prepare and send Pre-announcements for new products to all Cochlear Middle East Distributors
  • Initiate improvement activities & Support improvement initiatives within Cochlear
  • Monitor the status of CAPA’s, prepare key performance metrics and distribute

Key Requirements:

  • Familiar with use of International Quality Management System standards, Quality Management System Auditing certification (ISO 13485:2016, ISO 9001:2008)
  • Bachelor’s Degree in relevant field
  • Ability to create and maintain strong working relationships with customers and internally.
  • Strong organisational skills and attention to details
  • Experience working in Middle East – minimum 3 years
  • Experience with Regulatory and/or Legal processes – minimum 5 years
  • Experience in healthcare, medical device, pharmaceutical or similar industry
  • Strong interpersonal and communication skills (spoken and written)
  • Ability to influence and work across cultures
  • Self-motivated with demonstrable drive, commitment and achievement orientation

General:

Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).

 

Advertised: Arabian Standard Time
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