Medical Device Regulatory Affairs Strategist

Role Overview

Medical Device Regulatory Affairs Strategist at Oracle, based in a location supporting Oracle's Healthcare and Life Sciences business units with focus on Middle East and Africa regulatory markets.

Company Overview

Oracle's Healthcare and Life Sciences business units operate in a rapidly evolving global regulatory environment, requiring deep expertise in public and private sector levers that impact the medical device and software-as-a-medical-device (SaMD) industry.

Role Purpose

To drive Oracle's competitiveness and market access in healthcare and life sciences by developing and executing regulatory strategy for medical device and SaMD products across Middle East and Africa countries, ensuring compliance with complex and evolving regional regulations while collaborating across all Oracle business units that serve health and life sciences industries.

Key Responsibilities

Regulatory Strategy and Submissions

• Work closely with Oracle's product engineering teams to assess product functionality and develop regulatory strategy for Middle East and Africa countries.
• Collaborate cross-functionally to create and manage submissions for health authorities including SFDA (Saudi Arabia), MOHAP (United Arab Emirates), MOPH (Qatar), NHRA (Bahrain), SAHPRA (South Africa), NAFDAC (Nigeria), EDA (Egypt), and PPB (Kenya).
• Ensure ongoing compliance with regulatory authorities across all assigned markets.
• Review and recommend changes to labeling, marketing materials, clinical protocols, design processes, and procedures to maintain regulatory and quality compliance.

Compliance and Documentation

• Maintain regulatory documentation, technical files, and post-market surveillance activities ensuring ongoing compliance with applicable regulations.
• Maintain compliance with changing regulatory requirements across global markets that impact our businesses, regulatory affairs function, and quality/compliance programs.
• Perform evaluation of internal operations, controls, communications, and risk assessments related to regulatory compliance.
• Recommend appropriate changes to compliance processes and documentation.

Audit and Risk Management

• Support internal and external audits to identify, evaluate, disclose, and appropriately remedy risks and deficiencies.
• Conduct and facilitate internal and external audits to identify, evaluate, disclose, and appropriately remedy risks and deficiencies.
• Execute risk assessments and evaluate risks to the business.
• Develop risk mitigation strategies aligned with industry standards and Oracle policies.
• Understands continual improvement and risk management.

Stakeholder and Subject Matter Expert Engagement

• Serve as a subject matter expert for internal clients with interpretation of applicable standards, regulations, and use of the quality management system.
• Build effective working relationships with regulatory agencies, affiliates, and cross-functional stakeholders to support aligned and practical regulatory outcomes.
• Serve as point of contact for interactions with regulatory agencies for defined matters.
• Develop training for GBU development, cloud services, services, and operations teams on industry regulatory specifications applicable to their products and services.

Project and Program Management

• Manage regulatory and compliance-related projects for health-related products.
• Coordinate 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.
• 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 (for example, PCI, HIPAA, HITECH, ISO, SOC2).
• Execute a vendor security and/or quality management program.

Security and Quality Documentation

• Build security documentation and collateral for customers and internal users allowing security to be a differentiator.
• 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 for alignment with regulatory requirements.

Reporting and Metrics

• Build management-level metrics and reporting for activities owned by regulatory affairs and risk management functions.

Qualifications & Experience

• 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, and Product Development in medical device industry or equivalent.
• Experience authoring submissions across assigned Middle East and Africa markets required.
• Experience with sustaining and new product development is ideal.
• Comprehensive knowledge of regulatory requirements and processes across Middle East and Africa countries.
• Demonstrated experience interpreting local regulations and supporting market access, lifecycle compliance, and health authority engagements.
• Experience working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 62304, 21 CFR parts 1000/1001.
• Experience engaging with regional trade associations, industry groups, or regulatory forums.

Skills & Competencies

• Strong problem-solving, planning, and organizational skills.
• Ability to manage multiple priorities and work independently in a fast-paced, cross-cultural environment.
• Ability to adjust and adapt to changing priorities in a dynamic environment.
• Ability to perform in a fast-paced and continually evolving business environment.
• Excellent written and verbal communication skills.
• Knowledge of continual improvement and risk management.

Additional Information

• Career Level: IC4
• This role requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape.
• The successful candidate will be collaborative, a creative problem solver, and dedicated to excellence in their work.