Job Purpose:
Responsible for the products registration and renewals, as well as the fulfilment of all regulatory requirements to import, market and utilize AMICO products. Key Responsibilities
Develop new regulatory policies, processes and Standard Operating Procedures and train key personnel on them.
Serve as Central Reference point for all regulatory affairs for both AMICO and its suppliers.
Assist as needed in providing necessary documentation or information to support import and export of regulated products, including FDA Importation Codes, and Certificates to Foreign Government for Medical Devices.
Monitor and advise impact of changing regulations on submission strategies and update internal stakeholders.
Assist in the development of multicountry regulatory strategy and update strategy based upon regulatory changes.
Assist in regulatory due diligence for potential and new acquisitions. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
Compile, prepare, review and submit regulatory submission to authorities. Report adverse events to regulatory agencies and internal stakeholders.
Represent AMICO to authorities whenever required.
Provide strategic input and technical guidance on regulatory requirements to development teams.
Qualifications - Minimum Requirements:
Bachelor’s degree or equivalent
Professional Certificates: RAC
Typically 10+ years industry experience in the medical device/pharmaceutical area, with 5+ years supervising Regulatory Affairs in the Gulf countries including KSA.
Competencies / Skills: Strong knowledge of gulf / middle east countries regulations.
Additional or Desirable Qualifications: Managerial skills, Project Management.
