Description

Job Description

Job Summary The Regulatory Affairs Manager is a key member of the Central Regulatory Affairs team, responsible for managing and coordinating medical device regulatory activities across multiple countries. The role focuses on harmonizing regulatory approaches, ensuring compliance with applicable regulations, and maintaining effective oversight of registration activities. The position requires strong coordination, structured reporting, and excellent communication abilities to ensure alignment across several teams located in different countries and timely regulatory outcomes.

Key Responsibilities Regulatory Strategy & Registration Oversight

• 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.

Qualifications & Experience Education

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

Reporting Line

• The Regulatory Affairs Manager reports to Regional Regulatory Affairs Managers

Why Join Us At AMICO, we believe in fostering a diverse and inclusive workplace. We recognize the value that different perspectives and experiences bring to our company.

As part of our commitment to diversity, we encourage applications from all individuals as part of our inclusive hiring practices.

This initiative is part of our broader diversity agenda aimed at creating a balanced and innovative workforce.