Senior Regulatory Affairs Specialist

at  Medtronic

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A DAY IN THE LIFE

We are seeking a dynamic and experienced Sr Regulatory Affairs Specialist to join our team in Dubai, United Arab Emirates. This role involves managing regulatory affairs across the Gulf area, ensuring our products meet all regulatory requirements.
The position offers the flexibility of working 2-3 days remotely, with the remaining days at our Dubai office. Occasional travel may be required to meet with regulatory agencies and attend industry conferences.

REQUIRED KNOWLEDGE AND EXPERIENCE:

• Experience: Minimum of 5 years of experience in regulatory affairs, with a proven track record in preparing, coordinating, and managing regulatory submissions, license renewals, and registrations.
• Education: Bachelor’s degree in a relevant field such as Life Sciences, Pharmacy, or a related discipline. Advanced degrees are a plus.
• GCC Knowledge: Must have comprehensive knowledge of GCC laws and government procedures, with experience in ensuring compliance with regional regulatory standards.
• Regulatory Compliance: In-depth understanding of regulatory compliance, labeling requirements, and clinical protocols, with experience in reviewing and recommending changes to ensure compliance with regulatory standards.
• Regulatory Updates: Up-to-date knowledge of current and evolving regulatory procedures and changes, with experience in staying informed about regulatory updates and implementing necessary changes.
• Agency Interaction: Knowledge of regulatory agency requirements and communication protocols, with direct experience in interacting with regulatory agencies and handling defined regulatory matters.

PHYSICAL JOB REQUIREMENTS

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

• Document Coordination: Oversee the preparation of document packages for regulatory submissions, internal audits, and inspections.
• Submission Management: Lead the compilation of materials for submissions, license renewals, and annual registrations.
• Compliance Recommendations: Suggest changes to labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance.
• System Monitoring: Improve and monitor tracking and control systems.
• Regulatory Updates: Stay updated on regulatory procedures and changes.
• Agency Interaction: Direct interactions with regulatory agencies on specific matters.