Medical Device Regulatory Affairs Strategist

About the role

Oracle is seeking a Medical Device Regulatory Affairs Strategist to lead regulatory strategy for its health‑tech products across the Middle East and Africa. The role bridges product engineering and regulatory compliance, ensuring Oracle’s solutions meet the fast‑changing requirements of health authorities.

Key responsibilities

• Partner with product engineering teams to evaluate functionality and define regulatory strategies for Middle East and Africa markets.
• Create and manage submissions to health authorities such as SFDA, MOHAP, MOPH, NHRA, SAHPRA, NAFDAC, EDA and PPB.
• Maintain regulatory documentation, technical files and post‑market surveillance activities.
• Support internal and external audits, identify risks and implement corrective actions.
• Act as subject‑matter expert on standards, regulations and the quality management system for internal stakeholders.
• Lead regulatory and compliance projects for health‑related products.
• Review and advise on labeling, marketing materials, clinical protocols, design processes and procedures to ensure ongoing compliance.
• Build and sustain relationships with regulatory agencies, affiliates and cross‑functional teams.

Required profile

• Bachelor’s degree in pharmacy, biology, biomedical engineering, life sciences, health sciences or a related field.
• Proven experience with software‑as‑a‑medical‑device (SaMD) in regulatory affairs, quality compliance or product development within the medical device industry.
• Demonstrated ability to author regulatory submissions and manage compliance activities across multiple jurisdictions.

Required skills

• Regulatory strategy development for medical devices.
• Regulatory submission preparation and management.
• Technical file and post‑market surveillance management.
• Quality management system expertise.