Specialist Regulatory Affairs Abbott Laboratories Dubai

Abbott Laboratories is presently looking for Specialist Regulatory Affairs – Middle East and Africa to join them in Dubai. This is a recently opened position at the company and is open for applications now. This position performs and supports the RA Manager, Middle East and Africa / with implementation of specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the regulatory registration in the Middle East.

Responsibilities of Specialist Regulatory Affairs

• Prepares robust regulatory applications (for regulatory agencies in the Middle East and Africa) to achieve departmental and organizational objectives.
• Reviews and approves business unit change requests having assessed the impact on regulatory submissions.
• Acts as a contact in relation to EMEA and International RA staff.
• Provides review and analysis of applicable regulatory guidelines and regulatory assessments as needed.
• Reviews and evaluates regulatory documentation and provides registration submissions to ensure they convey all necessary details.
• Maintains pertinent medical device regulations in the Middle East Region to ensure submission requirements are current, up-to-date and are communicated to business unit colleagues.
• Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• May interface directly with Saudi FDA and other regulatory agencies.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, EU MDR, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, regulators, distributors and customers.
• Liaise with Abbott International/Product Divisions and Business Units 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 adherence to projects and commitments.
• Provide metrics, reports and feedback to management as required to enable tracking of regulatory activities.
• Support new product introductions, tender and reimbursement activities by providing appropriate regulatory and quality documentation as required.
• Build strong relationship with stakeholders and sales team and notify them for any regulatory updates that impact sales.

Qualifications & Experience

Following are the requirements for the role of Specialist Regulatory Affairs – Middle East and Africa at Abbott:

• Bachelor’s degree in Biology or Science.
• Some experience or knowledge of regulatory affairs activities and adherence to quality management systems requirements is desirable.

Knowledge & Skills

• Knowledge and experience of the application of regulations relevant to the medical device industry. Awareness of the role and remit of local regulatory authorities.
• 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.
• The ability to act with honesty and integrity at all times.

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