Job Description
Primary Responsibilities Include
- Support the business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s).
- Provides direct assistance with registering new and existing products supplied by Medline to the MEA region.
- Liaison with internal departments (ie Legal, Marketing, Supply Chain, QA & Regulatory) and distributors to ensure registration.
- Liaising and negotiating with foreign regulatory authorities.
- Liaise with suppliers when needed to obtain documents needed for registration.
- Gathering, reviewing, organizing, and assembling all regulatory-related information on registration instructions and regulations in various formats.
- Complete forms and requests originating from foreign government agencies.
- Provide an effective follow-up during the registration process to ensure the completion of the product registration.
- Ensuring compliance with MOH regulations in the MEA region.
- Proactively liaising with Distributors regarding new regulations to maintain regulatory changes.
- Identify and communicate any potential for improvements in view of reducing time to market.
Minimum Job Requirements Include
- A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices, OR a minimum of 3 years’ experience in Quality and Regulatory Affairs Management in a Medical Device
- Excellent knowledge of the ISO 13485; and product registration
- Proven ability to work collaboratively across functional departments;
- Understanding of the current Regulatory environment and demonstrating the ability to perform within.
- Ability to evaluate information to determine compliance with standards, laws, and regulations
- Excellent written and oral communication skills; fluency in English and Arabic are required.
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