Medical Device Regulatory Affairs Strategist

Job Description

• At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws, regulations, and public policies across the globe. 
• In this context, we are looking for regulatory affairs experts in the med-tech space to play a key role in driving Oracle's success and competitiveness in the healthcare and life sciences sector. 
• You will work primarily with the Oracle Health & Life Sciences business units but will also interact with all Oracle business units selling products to the health and life sciences industries. This role requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape. For this role we are seeking a regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence in their work. 

What You’ll Do:

• 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) ensuring on going compliance with regulatory authorities.
• Maintain regulatory documentation, technical files, and post market surveillance activities ensuring ongoing compliance with applicable regulations.
• Support internal and external audits to identify, evaluate, disclose, and appropriately remedy risks and deficiencies.
• Serve as a subject matter expert for internal clients with interpretation of applicable standards, regulations, and use of the quality management system.
• 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 that impact to our businesses, regulatory affairs function, and quality/compliance programs.
• Build effective working relationships with regulatory agencies, affiliates, and cross-functional stakeholders to support aligned and practical regulatory outcomes.

Preferred Qualifications:

• 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.