Medical Device Regulatory Affairs Strategist

Medical Device Regulatory Affairs Strategist

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

Disclaimer

Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.