Specialist, Regulatory Affairs – Middle East & Africa
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Regulatory Affairs Specialist supporting Abbott medical device registrations across the Middle East and Africa. Preparing submissions, maintaining regulatory compliance, and supporting market entry activities.
Responsibilities:
- Prepare robust regulatory applications for regulatory agencies in the Middle East and Africa
- Review and approve business unit change requests after assessing impacts on regulatory submissions
- Review and analyze applicable regulatory guidelines and assessments
- Review and evaluate regulatory documentation and provide registration submissions compliant with applicable standards, including Saudi FDA requirements
- Maintain current medical device regulations and communicate new or modified requirements to business unit colleagues
- Interface directly with Saudi FDA and other regulatory agencies as needed
- Comply with FDA, international, EU MDR and other regulatory requirements, as well as company policies and procedures
- Collaborate with employees, regulators, distributors and customers
- Liaise with Abbott International, Product Divisions, Business Units and International RA staff
- Implement databases and tracking tools for projects and commitments
- Provide metrics, reports and feedback to management
- Support new product introductions, tender and reimbursement activities with regulatory and quality documentation
- Build relationships with stakeholders and sales teams and notify them of regulatory updates impacting sales
Requirements:
- Bachelor’s degree in Biology or Science
- Some experience or knowledge of regulatory affairs activities and adherence to quality management systems requirements is desirable
- Must be proficient in English and Arabic
- Knowledge and experience of regulations relevant to the medical device industry
- Awareness of the role and remit of local regulatory authorities
- Competent user of Microsoft Office packages
- Capability and strong working knowledge of Excel is desirable
- Good communication skills
- Critical thinking and ability to challenge appropriately
- Strong attention to detail
- Highly organised and efficient, with ability to meet deadlines
- Ability to act with honesty and integrity at all times
Benefits:
- Career development with an international company
- Recognition as a great place to work in dozens of countries
- Recognition as one of the best big companies to work for and a best place to work for diversity, working mothers, female executives and scientists
- Equal Opportunity Employer committed to employee diversity
Similar Jobs
Director, Regulatory Affairs – Advertising, Promotion and Labelling
Regulatory affairs director guiding FDA-compliant promotion, medical communications, and global labelling for Autolus cancer and autoimmune therapies. Leading cross-functional strategies, reviews, submissions, and governance.
Compliance Manager
Compliance Manager building scalable EU/EEA compliance frameworks for DayOne’s hyperscale data centers. Developing policies, risk controls, regulatory processes, training, and investigations across jurisdictions.
Regulatory and Site Start Up Specialist
Regulatory specialist supporting clinical trial submissions, essential documents, and site activation for Precision for Medicine, a life sciences CRO. Coordinating Australian clinical trial start-up activities and regulatory compliance.
Regulatory and Site Start Up Specialist
Regulatory specialist supporting clinical trial submissions and site activation for Precision for Medicine, a life sciences CRO. Managing essential documents, ethics approvals, contracts, and country-specific compliance.
Senior GRC Consultant – Contract
Senior GRC Consultant delivering ISO, SOC 2, and GDPR compliance programs for Sprinto’s autonomous trust platform. Building AI-assisted playbooks and owning client engagement quality, margins, and delivery.
Compliance Operations Expert
Compliance operations expert designing global fiat, crypto, and stablecoin payment compliance solutions for Bybit. Supporting licensing, regulatory strategy, and cross-border settlement across LATAM, EU, and MENA.
Senior Manager, Compliance Operations
Renew Home compliance manager overseeing SOC 2, SOX, and ISO 27001 programs. Managing audits, controls, evidence, and cross-functional security compliance operations for residential energy technology.
Compliance Advisor
Compliance Advisor securing Gainwell Technologies’ healthcare technology environment and managing SOC, NIST, HIPAA, and access-control compliance. Guiding security teams and improving enterprise security procedures.
Compliance Advisor
Compliance Advisor securing Gainwell Technologies’ healthcare technology environment. Managing audits, access controls, vulnerabilities, and corporate security compliance.
Compliance Advisor
Compliance Advisor securing Gainwell’s healthcare technology environment. Managing audits, access reviews, threat controls, and security compliance programs.
Compliance Advisor
Compliance Advisor overseeing healthcare security audits, access controls, and vulnerability management at Gainwell Technologies. Supporting safer Medicaid and healthcare technology operations.
Director, Regulatory – Carbon
Shell carbon regulatory director advising environmental products trading, RNG origination, and renewable energy businesses. Monitoring North American regulations, guiding compliance, and advocating competitive market policies.
Compliance Engineer
Compliance Engineer building automated security and compliance controls for Retell AI’s voice AI call-center platform. Supporting audits, enterprise security reviews, and scalable compliance systems.
Director, Regulatory Operations
Director overseeing Centene’s Ambetter regulatory compliance operations. Ensuring Marketplace healthcare products meet CMS, state, and federal requirements.
Compliance Officer
Nigeria Compliance Officer analyzing visa refusals and applicant risk for Global University Systems, an international education group. Improving recruitment quality, agent compliance, and UK student visa outcomes.
Compliance Officer
Compliance Officer supporting AML/KYC controls, regulatory adherence, and high-risk due diligence at Mashreq. Contributing to compliance systems, training, reporting, and bank-wide policy development.
Compliance Analyst – Senior Compliance Analyst, Special Investigations
Compliance Analyst investigating blockchain transactions and complex AML cases for OKX, a leading crypto exchange and wallet developer. Assessing illicit activity, regulatory risk, and transaction-monitoring controls.
Director of Global Trade Compliance
Director leading global trade compliance for Voyager’s space, defense, and national security technology company. Overseeing export controls, customs, sanctions, licensing, and compliance operations.
Senior Consultant, Regulatory Audit and Internal Controls
Consultor sênior conduzindo auditorias regulatórias, testes de controles e avaliações de riscos em empresas financeiras e seguradoras. Elaborando relatórios técnicos em português e inglês.
Compliance Analyst
Compliance Analyst supporting regulatory reporting, player-data analysis, and betting-integrity investigations for White Hat Gaming’s iGaming platform. Fully remote role collaborating across a global compliance team.