RA Officer CIS

Job description

JOB DESCRIPTION:

Main responsibilities:

• Responsibility for developing a comprehensive registration strategy in the countries of responsibility (Kazakhstan, Kyrgyzstan, Belarus, Ukraine, Tajikistan, Uzbekistan & Armenia) in close cooperation with the personnel dealing with sales, operations and marketing, taking into consideration Company's interests and normative requirements.
• Responsibility for insuring earliest possible registration of all new or in-line products, along with the re-registration/making changes according to adopted registration strategies (and company's high ethical standards policy).
• Reviewing registration files and all related documentation of the Company's products and preparing such documentation in line with local normative regulations.
• Preparing Application Forms and other documentation for filing and registration of new products. Ensuring that all documentation, samples, commercial packs and other items are provided to relevant agencies as needed.
• Establishing and maintaining good working relationships with all involved regulatory and other institutions. Keeping track of new regulations related to registration of medical devices.
• Cultivating best possible relations with local regulatory providers and opinion leaders and enhancing the Company's image in the medical community in general.
• Handling all issues related to changes in the Company's products status and performing regulatory related surveys in the country.
• Preparing and reviewing package labels and inserts for Company's respective new and in-line products registered in the country.

Requirements:

• Higher education
• At least 2 years of experience in Regulatory Affairs (medical devices, pharmaceuticals)
• Strong willing to develop in IVD regulatory affairs field;
• English – written, spoken (Upper-Intermediate)
• Excellent knowledge of MS Office (Word, Excel)
• Personality: team player, well organized, attentive to details, enthusiastic, quick learner
• Ability to work with big amount of information

JOB FAMILY:

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