Regulatory Affairs Manager

Company Name: farabimedical
Location: SaudiArabia
Posted by:

farabi medical

farabi medical

HR at farabimedical

Managing the complete Saudi food & Drug Authority (SFDA) Registration Department which includes the following Processes:

Ø Responsible for the presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorization for the products concerned

Ø Review, evaluate, and compile files and reports for submission.

Ø Gathering, evaluating, organizing, managing and collating information in a variety of formats

Ø Planning, undertaking and overseeing product trials and regulatory inspections

Ø Outlining requirements for labeling, storage, and packaging

Ø Liaising and negotiating with regulatory authorities

Ø Providing advice about SFDA regulations to manufacturers

Ø Preparing submissions of license variations and renewals to strict deadlines;

Ø Monitoring and setting timelines for license variations and renewal approvals;

Ø Authorized Representative Process (AR)

Corresponding with the manufacturers for the Authorized Representative process. Detailing them the requirements for appointing the Authorized representative in Saudi Arabia.

 Renewal of Expired AR along with study with implementing any new terms as per the company policy.

Attending the meeting with manufactures for AR and MDMA issues.

Ø Medical Device Marketing Authorization process (MDMA)

·          MDD/IVD/Dental products

·          Experience of working on registering documents from Various Jurisdictions which includes: US, EU, CANADA, Japan &TGA

Ø Medical Device Importing Licensing process (MDIL)

·        Providing the necessary documentation for the Shipment Clearances.

·         Contacting SFDA authorities in case of any hindrances in shipment release.

·         Handling the clearance of chemical items and non-medical devices by contacting the classification team in SFDA.

Ø National Center For Medical Devices Reporting (NCMDR)

Ø Contacting regularly with SFDA authorities for discussing and solving hindrances occurred in shipments clearances.

Ø Able to handle multiple projects and exercise good judgment in prioritizing tasks

Ø Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.

Ø Monitor company progress toward fulfillment of regulatory commitments. 

Bio-Medical Engineers preferable

Saudi Nationals Only

• Seniority level

  Mid-Senior level

• Employment type

  Full-time

• Job function

  LegalHealth Care Provider

• Industries

  International Trade and DevelopmentBiotechnologyHospital & Health Care