Cochlear Dubai Jobs 2022 – Apply Online Regulatory Coordinator Vacancy in Dubai, UAE

Job no: 614529

Work type: Permanent

Categories: Quality & Regulatory, Middle East & Africa, Individual Contributor

Cochlear develops world-leading medical devices that help people hear. As the top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear 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.
An exciting opportunity has arisen for a Regulatory Affairs Coordinator to join our team in Dubai Office

The Regulatory Affairs Coordinator will become specialized in both the cochlear implant and acoustic portfolio and associated responsibilities in Middle East and Africa. In this position you will report to Regulatory and Quality Affairs Manager, MEA who is located in Dubai. You will have a close collaboration with the fellow Regulatory Affairs colleagues in EMEA with focus on the support of product regulatory submissions, renewals, MDR transitions, product life-cycle, change assessments and quality of manufacturing processes to meet requirements in MEA Countries.
This position will involve significant cross-functional communication and participate in activities across all departments within the MEA region, as well as our counterparts throughout EMEA and globally.

Duties and Responsibilities:

• Provide administrative support for the activities conducted by Regulatory Affairs department
• Interactions with business partners on monitoring and control over the using of our medical device
• Tracking the law enforcement practice new and revised regulatory requirements for a medical device for all relevant countries within the MEA region and maintaining records of legislations, regulations and guidelines
• Timely changes in the documentation on medical device: analyse the necessary actions to update the impacted documentation
• Administration of activities and follow ups to support countries complete local registrations, renewals and trigger timely renewal with distributers as well as transition of products through MDR processes and any other changes under supervision of Quality and Regulatory Manager
• Gather, document and maintain regulatory intelligence information for premarket and post market requirements for all relevant countries within MEA region and support to fulfil any commitments required by regulatory agencies
• Support in preparation of local regulatory submission dossiers for all relevant countries within MEA region
• Establish a good relationship with business partners, assist in organizing meetings and communicate information related to Regulatory Affairs function. Also communicate and track updates in the regulatory environment for all relevant countries within MEA region.
• Support and provide feedback to regulatory document requests from sales managers/distributors for tenders
• Participate in, and contribute ‘Lessons Learned’ to evaluate and improve the process for tender Management
• Support daily business and operations by preparing required documents, like legal documents, agreements and statements, that might be requested from time to time. Prepare documents as per their template, coordinate with other departments for signature, archive documents and/or copies both digitally and physically
• Supporting the quality and Regulatory Manager in project tasks as they arise
• Quality and Regulatory Manager MEA back-up during absences

Key Requirements