Job Description

Roles & Responsibilities

Key Responsibilities

• Manage and oversee medical device registration activities with his team to ensure timely approvals and lifecycle maintenance.
• Define and apply harmonized regulatory strategies, documentation standards, and submission approaches across markets.
• Ensuring that his team are providing a complete file for submission, accurate, and compliance with applicable regulations.
• Ensure consistency in regulatory positioning while accommodating justified country specific requirements.

Cross Country Coordination & Team Management

• Act as the central coordination point between the central Regulatory Affairs function and the local regulatory team.
• Conduct regular periodic meetings (e.g., weekly or monthly) with country regulatory / marketing & different managers to:
  
  • Review registration status and upcoming submissions
  • Address regulatory challenges and authority feedback
  • Align on scope of work and priorities, timelines, and workload
• Provide guidance, and regulatory direction to ensure aligned execution across the different business units.
• Ensure optimum allocation of responsibilities.

Tracking, Reporting & Data Management

• Establish, maintain, and continuously improve registration tracking systems covering:
  
  • Submissions, approvals, renewals, variations, actions taken and regulatory commitments
  • Country specific timelines.
• Prepare and deliver periodic regulatory status reports to senior management, highlighting progress, risks, delays, and mitigation actions.

Reporting & Stakeholder Interaction

• Provide structured and clear regulatory updates to superiors and senior stakeholders during management reviews and ad hoc requests.
• Communicate regulatory risks, authority feedback, and potential impacts in a timely and transparent manner.
• Collaborate closely with Quality, Supply Chain, Commercial, and other internal functions to support product availability and compliance.

Desired Candidate Profile

Education

• Bachelor s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
• Previous experience in the Gulf Cooperation Council (GCC) strong> registrations are an advantage.

Professional Experience

• 5-7 Years experience in medical device regulatory affairs, preferably in a regional or multi country centralized role.
• Experience managing or coordinating work across several countries and regulatory teams.

Skills & Competencies

• Strong knowledge of medical device regulatory requirements and registration lifecycle management.
• Strong organizational and coordination skills with attention to detail.
• Excellent communication skills, with the ability to lead discussions, conduct structured meetings, and clearly convey regulatory expectations.
• Ability to manage multiple priorities and work effectively in a matrix organization.