Quality & Regulatory Affairs Specialist

BD

Doha

On-site

QAR 90,000 - 130,000

Full time

6 days ago
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Job summary

BD in Qatar seeks a Quality & Regulatory Affairs (QRA) Specialist to support regulatory submissions, registrations, and lifecycle management across Qatar and GCC/MENA regions.

You will help maintain QMS processes, ensure compliance for advertising materials, and coordinate with authorities, distributors, and internal stakeholders to enable timely product launches and ongoing market compliance.

Qualifications

  • Bachelor's degree in science with regulatory/quality exposure.
  • Experience with product registrations, renewals, variations, and import permits in GCC/MENA.

Responsibilities

  • Prepare and submit regulatory dossiers for product registrations, renewals, variations, and lifecycle maintenance.
  • Coordinate with Qatar authorities and distributors to ensure timely approvals and compliance.
  • Monitor regulatory changes and implement new requirements across portfolios.
  • Support local QMS processes, SOPs, trainings, audits, and CAPAs.
  • Assist in post-market surveillance, complaint handling, and FSAs in collaboration with regional teams.
  • Collaborate with commercial, supply chain and regional QRA teams for launches and tenders.

Skills

Regulatory affairs
Quality management
Cross-functional teamwork
Documentation control
Post-market surveillance
QMS
GCC/MENA regs

Education

Bachelor's degree in pharmacy
Life sciences or related

Tools

Regulatory databases
MS Office

Job description

We Are The People Who Give Possibilities Purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
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.
Regulatory Coordination & Stakeholder Support
  • 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.
Regulatory Intelligence & Compliance Monitoring
  • 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.
Quality Assurance & QMS Support
  • 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.
Post-Market Surveillance & Field Actions
  • 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.
Operational Support & Cross-Functional Collaboration
  • 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.
About You
  • 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.
Why Join Us?
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
Primary Work Location
QAT Qatar – Field Only
Additional Locations
Work Shift
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