Medical Device Regulatory Affairs Strategist📣 Job Ad

About the Role

Oracle is seeking a Medical Device Regulatory Affairs Strategist to join its team in Saudi Arabia. This full-time role requires 5-10 years of experience and is critical for driving Oracle's success and competitiveness within the healthcare and life sciences sector. The strategist will navigate complex and evolving laws, regulations, and public policies globally, particularly in the med-tech space.

Role Context and Impact

This position involves working primarily with Oracle Health & Life Sciences business units, as well as other Oracle units that sell products to the health and life sciences industries. The role demands an individual who can adapt to the fast-paced environment of software development and a dynamic regulatory landscape. The ideal candidate will be collaborative, a creative problem solver, and dedicated to excellence in their work, ensuring ongoing compliance with regulatory authorities amidst rapid global technological and healthcare regulatory changes.

Key Responsibilities

• Collaborate with Oracle’s product engineering teams to assess product functionality and develop regulatory strategies for Middle East and Africa countries.
• 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).
• Maintain regulatory documentation, technical files, and post-market surveillance activities to ensure ongoing compliance.
• Support internal and external audits to identify, evaluate, disclose, and remedy risks and deficiencies.
• Serve as a subject matter expert for internal clients on applicable standards, regulations, and quality management systems.
• Manage regulatory and compliance-related projects for health-related products.
• Review and recommend changes to labeling, marketing materials, clinical protocols, design processes, and procedures to maintain regulatory and quality compliance.
• Maintain compliance with changing regulatory requirements across global markets impacting businesses, regulatory affairs, and quality/compliance programs.
• Build effective working relationships with regulatory agencies, affiliates, and cross-functional stakeholders.

Additional Duties

• Perform evaluations of internal operations, controls, communications, and risk assessments related to regulatory compliance.
• Coordinate the preparation of document packages for regulatory submissions and audits.
• Serve as a point of contact for interactions with regulatory agencies on defined matters.
• Support the creation of comprehensive risk management, quality management, and regulatory oversight programs.
• Develop training for GBU development, cloud services, and operations teams on industry regulatory specifications.
• Execute risk assessments and develop mitigation strategies.
• Coordinate industry and regulatory certifications, including managing certification vendors (*, PCI, HIPAA, HITECH, ISO, SOC2).
• Build security documentation and collateral for customers and internal users.

Qualifications and Experience

• Minimum of 5-10 years of experience in regulatory affairs, specifically within the med-tech space.
• Demonstrated ability to navigate complex and fast-changing laws, regulations, and public policies.
• Experience with health authority submissions in the Middle East and Africa region.
• Strong understanding of quality management systems and regulatory compliance.
• Career Level - IC4.

Application Process

Candidates interested in this full-time position are encouraged to apply. Salary information will be disclosed during the recruitment process.