Oracle
Computers + 1 more
Description
Requirements
- Bachelor’s degree in pharmacy, Biology, Biomedical Engineering, Engineering, Life Sciences, Health Sciences, or a related field.
- Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring submissions across assigned Middle East and Africa market required. Experience with sustaining and new product development is ideal.
- Comprehensive knowledge of regulatory requirements and processes across Middle East and Africa countries, with demonstrated experience interpreting local regulations and supporting market access, lifecycle compliance, and health authority engagements.
- Strong problem-solving, planning, and organizational skills, with the ability to manage multiple priorities and work independently in a fast-paced, cross-cultural environment.
- Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 62304, 21 CFR parts 1000/1001,
- Understands continual improvement and risk management. Excellent written and verbal communication skills.
- Experience engaging with regional trade associations, industry groups, or regulatory forums.
- Ability to adjust and adapt to changing priorities in a dynamic environment.
- Ability to perform in a fast-paced and continually evolving business environment.
Responsibilities
- Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes.
- Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections.
- May serve as point of contact for interactions with regulatory agencies for defined matters.
- Support the creation of a comprehensive risk management and/or quality management, and regulatory oversight program, including specifications for product and service design aligned with Oracle Software Security Assurance and Security Architecture, and/or Quality Management systems.
- Review specifications.
- Develop training for GBU development, cloud services, services and operations teams on industry regulatory specifications applicable to their products and services.
- Execute risk assessments and evaluate risks to the business and develop risk mitigation strategies.
- Identify industry requirements applicable to Oracle GBUs, and work with members of GBU development, cloud services, services and operations teams to incorporate applicable industry regulatory standards, Oracle security and/or quality policies and customer-contractual obligations into GBU processes and standards.
- Coordinate industry and regulatory certifications, including managing certification vendors (e.g., PCI, HIPAA,HITECH, ISO, SOC2).
- Build security documentation and collateral for customers and internal users allowing security to be a differentiator in this GBUs.
- Build management level metrics and reporting for activities that are owned by the Risk Manager.
- Execute a vendor security and/or quality management program.
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