Regulatory Affairs Manager

Regulatory Affairs Manager

Position:
Regulatory Affairs Manager in UAE, Abbott Rapid Diagnostics Division.

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking toward the future, anticipating changes in medical science and technology.

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• 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 that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

We are the world leader in Rapid Diagnostics at the point of care. Working with us, you'll tackle a wide array of problems including some of the world's greatest healthcare challenges, while experiencing a myriad of cultures, geographies, and technologies.

This position works out of our UAE location in the Abbott Rapid Diagnostics Division. As Regulatory Affairs Manager, you will coordinate and manage the Regional Regulatory activities for the Infectious Disease portfolio and assist with specific regional regulatory tasks as required. This includes defining, implementing and managing RA processes, ensuring product registrations are acquired and alternative pathways established to ensure compliant import of product to countries’ strategies for product launches.

• Support in the preparation of product registration plans in accordance with business strategies for review and approval by the Regulatory Affairs Director EMEA.
• Collaborate with Abbott Global Regulatory teams and Abbott Legal Manufacturer RA counterparts to stay informed on high-level regulatory strategies and key certification approval timelines for new products.
• Provide input to product-launch core teams regarding Regional Regulatory strategies for product launches and new market expansion projects.
• Interact with regulatory agencies to expedite registration approvals.
• Serve as the regulatory liaison throughout the product life cycle.
• Participate in product plan development and implementation, regulatory strategy, risk management, and commercial strategies.
• Represent development and marketing teams to regulatory agencies.
• Advise on manufacturing changes, line extensions, technical labeling, and appropriate regulations and interpretations.

• Ensure the preparation and timely completion of registration submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs.
• Participate in cross‑functional project teams to provide input that enables strategic guidance for new product introductions.
• Conduct regulatory impact assessments for new product introductions and assist in development of registration plans.
• Assess and document changes in product, IVDR changes, manufacturing processes, labeling impacting IVD products in the region.
• Work closely with commercial regional teams to align on business requirements.
• Ensure efficient review of advertising and promotional materials for compliance with local country specific requirements.
• Oversee regulatory compliance for registrations held under Abbott entities and distributors.
• Work with authorities and authorized representatives to resolve queries arising from registrations, event reporting, post‑market surveillance, promotional material review, and trademark applications.
• Support legal manufacturers in reporting complaints, adverse events, and FSCA/FSN notifications to regulatory authorities.
• Keep abreast of regulation changes and develop compliance strategies while minimizing impact on business.

• Oversee gathering and collation of regulatory intelligence (new or changing medical device & IVD regulations) in the defined region.
• Coordinate dissemination of its…