[Hiring] Regulatory Affairs Specialist @Abbott

Role Description

The position works out of our Lebanon location in Abbott Medical Devices Division.

As RA Specialist, you will perform and support the Senior 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. This is performed ensuring products and procedures comply with regulatory agency specifications. Leads and supports necessary regulatory activities required for product market entry while making the necessary assessments.

• 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.
• 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 detail and adhere to applicable regulatory standards including those set by the Saudi FDA and/or other regional regulatory agencies.
• 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 projects and commitments are adhered to.
• 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

• Bachelor’s degree in Biology or Science.
• Some experience or knowledge of regulatory affairs activities and adherence to quality management systems requirements is desirable.
• Must be proficient in English and Arabic.
• 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 organised, efficient and ability to meet deadlines.
• The ability to act with honesty and integrity at all times.

Benefits

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company recognized as one of the best big companies to work for, and a best place to work for diversity, working mothers, female executives and scientists.

Company 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, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.