Abbott Laboratories Hiring for RA Specialist – 1 year Contract Job at Dubai Full Time

Position Title: Regulatory Affairs Specialist Infectious Diseases ( IVD )

Location: Dubai – UAE

DO WORK THAT MATTERS.

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading point-of-care

Job Purpose:

Regulatory Affairs Specialist is responsible for supporting regulatory compliance and registration activities for the Abbott Rapid Diagnostics Infectious Disease in the defined geography relating to distributed products in the commercial businesses; whether owned directly by ARDx or owned by Distributors

RESPONSIBILITIES:

• Upholds the company’s core values
• Responsible for the implementation of regulatory compliance as required by international and local regulations and Abbott policies and procedures.
• Support the registration/re-registration activities of ARDx products in KSA and the Middle East.
• Support Middle East RA Manager with authorities in order to better understand regulations, build relationships and clarify issues.
• Facilitates gathering of regulatory intelligence
• Maintain Registration records.
• Maintain internal and divisional regulatory databases
• Supports as required for special projects assigned to the region.
• Provide support during audits as necessary
• Supports business operations in adverse event reporting
• Supports sites in contact with National Regulatory Agencies

Qualifications and Experience:

Experience:

• Preferably 1-3 years of experience in the medical device / IVD industry preferably in the area of Regulatory Affairs
• Knowledge of PC-based applications.
• Technical skills related to IVD or Medical Devices
• Knowledge of Submission on GHAD system SFDA
• Fluent in English (written and spoken

Education:

• Bachelor’s degree in Life Sciences or Engineering or Equivalent