Medical Device Regulatory Affairs Strategist– Health

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. 

As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device). You will help prepare the required documentation to register products in global markets where the products are sold. You will establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope. You will work on defining the regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising / promotion, etc.), as applicable. 

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. 

About the Business:

Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions to healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. We offer a range of products and services, including AI/ML solutions, cloud-based healthcare platforms, data analytics, electronic health records (EHR), and patient engagement systems. The business aims to help organizations improve patient outcomes, lower costs, and accelerate innovation. By leveraging Oracle's technology and expertise, healthcare and life science organizations can streamline their operations, gain insights from data, and make more informed decisions. Oracle also enables secure and compliant handling of sensitive healthcare data, helping organizations meet regulatory requirements and protect patient privacy. With a focus on digital transformation, Oracle's Healthcare and Life Sciences business empowers the industry to embrace modern technologies and improve overall healthcare delivery.

  What You'll Do:

• Work closely with Oracle's product engineering teams to assess product functionality and develop regulatory strategy. 
• Collaborate cross-functionally with other teams to create and manage pre-market submissions (including 510(k), CE Marking under EU MDR, Technical Files, applications to Health Canada, and other global submissions) across global market ensuring compliance with regulatory authorities.
• Maintain documentation and post market surveillance report on an ongoing basis to maintain market authorization.
• 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 and regulations, and use of the quality management system.
• Manage and compliance related projects for Health-related products.
• Review and recommend changes to labeling, marketing communications, clinical protocols, design processes, and manufacturing 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.

  Preferred Qualifications:

• BA/BS or advanced degree preferred. 
• Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring submissions (510k, EU Tech Files, etc.) required. Experience with sustaining and new product development is ideal.
• Experience interacting with notified bodies and/or regulators preferred. 
• Ability to perform in a fast-paced and continually evolving business environment.
• RAC, CQE, CPPS, CQA desired. 
• Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001, or Quality System Regulations. 
• Understands continual improvement and risk management. Excellent written and verbal communication skills. 
• Ability to adjust and adapt to changing priorities in a dynamic environment. 

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.

Career Level - IC4