Regulatory Affairs Specialist (1 Year Fixed Term Contract )
Dubai, United Arab Emirates
Job Description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutrition, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. ROLE OVERVIEW Abbott Rapid diagnostics team is looking for a Regulatory Affairs Specialist on 1-year contract basis (renewable) to be based in Dubai, UAE. This role will assist by providing regulatory and quality documentation / submission packages to the respective ME Regulatory Authorities in the region to support variations and changes to existing product registration approvals. This role will assist in product file compilation, submission, follow up with authorities while ensuring internal project management and coordination with Global and ME teams WHAT YOU'LL DO:
- Work with ME RA Manager and the International RA to obtain required documentation arising from CE marking of IVDs.
- Prepare and submit regulatory files and documentation to Regulatory Authorities in accordance with local ME country regulatory requirements
- Where notification of placing on the market is required, support the local Commercial Organization and ME RA by submitting documentation needed to meet local requirements.
- Liaise with the Abbott Business Unit Regulatory Affairs / Quality Assurance / Regulatory Compliance Departments as required to answer regulatory queries and ensure that local processes meet regulatory requirements.
- Liaise with the International RA Department staff. Implement databases and tracking tools to ensure projects, commitments and reporting requirements are adhered to.
- Provide metrics and feedback to management as required to enable tracking of regulatory activities in Middle East.
- Support products changes and impacts resulting from the EU IVDs, including but not limited to re-branding, tender and reimbursement activities by providing appropriate regulatory and quality documentation as required.
- Support and assist the local Regional Manager to implement to ensure no business interruption arising from the implementation of the IVDR.
- Educated to degree level in a science discipline or equivalent.
- 2-3 years of UAE/Saudi Arabia RA experience working in a regulated environment, preferably in IVDs is required.
- Some experience or knowledge of compliance activities and adherence to quality management systems requirements is desirable.
- Good communication skills in English and Arabic.
- Competent user of Microsoft Office packages. Capability and strong working knowledge of Excel is desirable.
- Good communication skills. Critical thinking and the ability to challenge appropriately.
- Strong attention to detail. Highly organized, efficient and ability to meet deadlines.
- Must be a team player, with the ability to work independently. Flexibility and the ability to cope with varying workload and demands as required.
- Must be able to work with integrity and in compliance with internal company policies and external regulatory requirements.
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Job Detail
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Job IdJD1412052
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationDubai, United Arab Emirates
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EducationNot mentioned