Quality & Regulatory Affairs Specialist

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.

This 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.

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 SOPs, training records, audits, complaint handling, CAPA, and post-market surveillance.

Experience working with cross-functional regional teams and external distributors or third-party service providers.

Knowledge of Qatar regulatory pathways for medical devices/IVDs, including registration, renewal, variation, importation, and post-market requirements.

Understanding of GCC/MENA regulatory frameworks and ability to interpret local authority requirements.

Familiarity with ISO 13485, GDP, complaint handling, vigilance, FSCA/FSN, CAPA, and document control.

Ability to prepare and maintain technical/regulatory documentation, submission trackers, approval records, and compliance files.

Strong ability to coordinate with distributors, health authorities, commercial teams, supply chain, and global/regional QRA teams.

Ability to monitor regulatory changes and translate them into practical actions for the business.

Good problem-solving, prioritization, follow-up, and escalation skills.

Proficiency in Microsoft Office and regulatory/quality documentation systems.

Fluency in English; Arabic would be valuable for authority/distributor communication.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills