Quality & Regulatory Affairs Specialist

Overview

Join BD, a leading global medical technology company dedicated to advancing health worldwide. This role is crucial in supporting Regulatory Affairs and Quality Assurance operations, primarily for Qatar and other MENA countries, ensuring compliance in product registration, importation, distribution, and post-market activities.

Key Responsibilities

• Prepare, submit, and manage regulatory dossiers for product registration, renewals, variations, and lifecycle maintenance following country-specific requirements.
• Maintain accuracy and completeness of submissions while monitoring timelines and liaising with local authorities and distributors to secure prompt approvals.
• Keep up-to-date regulatory files and documentation within procedural systems and support reviews of advertising materials to guarantee regulatory compliance.
• Serve as the primary Regulatory Affairs contact in Qatar, facilitating communication with national authorities directly or through third-party providers.
• Provide regulatory guidance for product launches to commercial and supply chain units and escalate any regulatory risks or delays accordingly.
• Monitor changes in regulatory landscapes and support the adoption of new compliance requirements affecting the product portfolio.
• Support the deployment and upkeep of local Quality Management System processes adhering to company SOPs and regulatory standards.
• Assist in documentation control, training record maintenance, audit preparedness, and quality investigations.
• Manage post-market surveillance including complaint handling, vigilance reporting, and coordinate Field Safety Corrective Actions in partnership with global teams.
• Provide QRA assistance for tenders, customer inquiries, and distributor questions, collaborating cross-functionally to ensure efficient product operations.

Qualifications & Experience

• Bachelor's degree in pharmacy, life sciences, biomedical engineering, or a related scientific area.
• Two to five years’ experience in regulatory affairs, quality assurance, or compliance within medical devices, IVD, pharmaceuticals, or healthcare sectors.
• Hands-on experience with regulatory processes including product registrations, renewals, variations, import permits, and distributor coordination specific to Qatar or GCC/MENA regions.
• Knowledge of Quality Management System procedures such as SOPs, training documentation, audits, complaint resolution, CAPA, and surveillance.
• Familiarity with Qatar’s medical device/IVD regulatory pathways and GCC/MENA regulatory frameworks including ISO 13485, GDP, vigilance, FSCA/FSN, CAPA, and document control requirements.
• Strong collaboration skills working with regional teams, distributors, and third-party service providers.
• Proficient in creating and managing technical/regulatory documentation, tracking submissions, and maintaining compliance records.
• Excellent organizational, problem-solving, prioritization and escalation capabilities.
• Proficiency in Microsoft Office tools and regulatory or quality systems.
• English fluency required; Arabic language skills are a plus for effective communication with authorities and distributors.

Additional Information

This role involves substantial cross-functional collaboration, with responsibilities spanning commercial, supply chain, and regional QRA teams to support operational success. BD values a culture of in-person teamwork to enhance learning and growth opportunities. BD is an equal opportunity employer, committed to diversity and inclusion across all legally protected categories.