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Job Description About the role
The Quality & Regulatory Affairs (QRA) Specialist supports Regulatory Affairs and Quality Assurance activities primarily in Qatar and other MENA countries, ensuring compliant product registration, importation, distribution, and post-market processes.
The role manages regulatory submissions, maintains documentation, and supports quality system activities in line with company standards and country regulatory requirements.
The role collaborates with the MENA QRA team, distributors, and internal stakeholders to support timely submissions, regulatory compliance, and effective operations in Qatar and other MENA markets, as needed.
Main Responsibilities Will Include Regulatory Affairs Execution & Compliance
- Prepare and submit regulatory dossiers for product registrations, renewals, variations, and lifecycle maintenance.
- Ensure all submissions are accurate, complete, and aligned with applicable country regulatory requirements.
- Track submission timelines and follow up with local authorities and distributors to ensure timely approvals.
- Maintain regulatory documentation and records in applicable systems.
- Support review of promotional and advertising materials for compliance with local regulations.
- Act as the key RA contact for Qatar with external and internal stakeholders.
- Support communication with Qatar National Authorities directly or through coordination with third party service providers.
- Provide regulatory input to commercial and supply chain teams for product launch readiness.
- Escalate regulatory risks, delays, or issues to line manager proactively.
- Monitor updates in regulatory requirements and share relevant changes with the team.
- Support implementation of new regulatory requirements.
- Maintain awareness of regulatory changes impacting product portfolio.
- Support implementation and maintenance of local Quality Management System (QMS) processes.
- Ensure compliance with internal SOPs and local regulatory requirements.
- Assist in documentation control, training records, and audit readiness activities.
- Support quality investigations and follow-up actions as required.
- Support complaint handling, vigilance reporting, and incident documentation.
- Coordinate execution of Field Safety Corrective Actions (FSCA/FSN) in collaboration with global and regional teams.
- Ensure completeness and timeliness of post-market documentation.
- Provide QRA support for tenders, customer requests, and distributor queries.
- Collaborate with commercial, supply chain, and regional teams to ensure smooth product flow.
- Maintain organized systems, records and reporting trackers for QRA activities.
- Bachelor’s degree in pharmacy, life sciences, biomedical engineering, or related scientific discipline.
- 2–5 years of relevant experience in regulatory affairs, quality assurance, or compliance within the medical device, IVD, pharmaceutical, or healthcare industry.
- Experience supporting product registration, renewals, variations, import permits, distributor coordination, and authority follow-up in Qatar or GCC/MENA markets.
- Practical experience with QMS processes such as…
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