Medical Device Regulatory Affairs Strategist

About the role

Oracle is seeking a Regulatory Affairs Strategist to support its Health & Life Sciences business units. The role focuses on developing and executing regulatory strategies for medical device software (SaMD) across Middle East and Africa markets.

Key responsibilities

• Collaborate with product engineering teams to assess functionality and define regulatory strategies for target countries.
• 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, identifying and remedying risks and deficiencies.
• Serve as subject‑matter expert on standards, regulations, and quality management systems.
• Lead regulatory and compliance projects for health‑related products.
• Review labeling, marketing materials, clinical protocols, and design processes for compliance.
• Build relationships with regulatory agencies, affiliates, and cross‑functional stakeholders.

Required profile

• Bachelor’s degree in pharmacy, biology, biomedical engineering, engineering, life sciences, health sciences, or a related field.
• Experience with SaMD in regulatory affairs, quality compliance, or product development within the medical device industry.
• Proven experience authoring regulatory submissions and managing compliance projects.

Required skills

• Regulatory affairs
• Quality compliance
• SaMD knowledge