Etanaa · Baghdad
Apr 15, 2023
Assist in regulatory submissions, maintain compliance for medical devices, prepare registration documents, stay updated with regulations, and coordinate with authorities and internal teams.
Regulatory affairs Job Announcement Etanaa company: A company for the trade of the medical devices and supplies specialized in the treatment of infertility, In Vitro Fertility) and the assisted reproductive technologies. Location: Iraq - Baghdad - AlJameaa Quarter Description: activities to assist in regulatory submission, annual reports, registrations, and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. Assist in the creation and maintenance of regulatory files. Responsibilities -Maintain regulatory files. Maintain and update regulatory authorizations. -Assist in preparing responses to regulatory authorities' questions within assigned timelines -Stay abreast of regulatory procedures and changes in the regulatory climate -Ensuring that all medical supplies and devices related to IVF meet local and international regulations and standards for safety and efficacy. -Staying up-to-date with local and international regulations related to medical supplies and devices used in IVF procedures. -Developing regulatory strategies for IVF product registration and approval. -Preparing and submitting regulatory applications for IVF product registration, renewal, and amendments to local regulatory authorities, such as the Iraqi Ministry of Health. -Coordinating with internal teams, such as quality assurance, and marketing, to ensure that all regulatory requirements are met throughout the product development process. -Reviewing product labeling and advertising materials to ensure regulatory compliance. -Conducting regulatory assessments of new and existing products to ensure ongoing compliance with local and international regulations. -Participating in internal and external audits related to regulatory compliance. -Maintaining accurate and complete regulatory documentation and records. Qualifications -Fluency in both Arabic and English, both oral and written, -Own a car. -The ability to move between different ministries related to work -Ability to manage multiple projects simultaneously and prioritize tasks to meet deadlines. -Excellent communication and interpersonal skills to interact with internal teams and external regulatory authorities -Bachelor's degree in a related field such as Chemistry, English department, or Biochemistry. If you were interested, email us your CV to [email protected] Or send it to our WhatsApp: 009647838884566
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