Regulatory Affairs Gulf Levant and Iraq Lead | Johnson & Johnson MedTech | UAE

About the Business

Role Purpose

Responsibilities

• Coordinate regulatory shaping and outreach with regulatory authorities and trade associations.
• Set annual regulatory submission plans across business, regional, and franchise stakeholders.
• Prepare registration submissions for direct and distributor-mediated routes.
• Manage submissions and follow up through completion of product registration.
• Assess regulatory changes affecting products, businesses, licenses, and patients.
• Escalate risks and recommend actions supporting business continuity.
• Ensure compliance for medical devices and medicinal products within timelines.
• Support tender management, importation, reimbursement, distributors, and franchises.
• Lead regulatory process improvements and ensure audit readiness.
• Manage direct reports and provide regulatory compliance updates to management.
• Coordinate copy review and escalate regulatory compliance issues.

Qualifications and Requirements

• Generally requires 4-6 years of work experience.
• University or bachelor's degree in science, biomedical science, or an equivalent field.
• English and Arabic language skills are required.
• Expertise in local and EU medical device regulations is required.
• Experience building relationships with competent authorities and trade associations is required.
• Strong interpersonal, organizational, detail-oriented, strategic thinking, and problem-solving skills are required.

Preferred Skills

• Preferred skills include compliance management, consulting, inclusive leadership, operational excellence, process improvement, quality assurance, and regulatory affairs management.
• Additional preferred areas include package and labeling regulations, product packaging design, safety orientation, sustainability, and team management.