Regulatory Affairs Specialist- MEA

Medline Europe


Date: 1 day ago
City: Riyadh
Contract type: Full time
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.

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Civil Inspector

WSP in the Middle East, Riyadh
2 minutes ago
We are WSP - Join us and make your career future ready!Think bigger scale. Think higher profile. Think ground-breaking. Join WSP, and you’ll be at the heart of a team of international experts all dedicated to growing and sharing their expertise and working on projects that transform society for all of us.WSP is currently seeking a detail-oriented and experienced Civil...

Senior Commercial Manager

KBR, Inc., Riyadh
21 hours ago
TitleSenior Commercial ManagerLOCATIONRiyadh, Saudi ArabiaProject DescriptionThe project is a major Built Environment mixed-use development aiming to be a global landmark recognized for its unique vision and position as an authentic destination in Riyadh. The community will be a distinct, self-sustaining hub for Riyadh offering several iconic assets. KBR will provide Project Management Consultancy services in project planning, controls, design and...

Manager - Corporate Sales (Pipeline)

Bupa Arabia, Riyadh
21 hours ago
Job DescriptionTo promote and sell Bupa Arabia’s products through direct and intermediaries’ channels with emphasis on medium to large and Major/Key clients by adapting with market dynamics, helping to fulfil the customers’ needs from the “prospecting stage” till the stage where the customer receives the activated cards whereby ensuring all services are provided by adhering to internal and external rules...