Regulatory Affairs Consultant for Medical Devices

About the Role: As the healthcare landscape rapidly evolves, the role of a Regulatory Affairs Consultant in the medical device sector has never been more crucial. We are seeking a talented professional to join Oracle, a pioneering company in health technology, dedicated to navigating complex regulations and maintaining our competitive edge. Your expertise will play a key role in overcoming regulatory hurdles and fostering innovation within the healthcare and life sciences industries. In this exciting position, you will work alongside product engineering and development teams focused on pioneering AI-driven, Cloud-native software applications aimed at enhancing clinical operations and decision support. You will be responsible for preparing vital documentation for product registrations in global markets and nurturing collaboration across business units to ensure our products meet regulatory compliance throughout their lifecycles. This role places a strong emphasis on teamwork, innovative problem-solving, and a commitment to excellence as you formulate regulatory strategies that impact product development, guide pre-market submissions, and manage post-market activities. Join us in driving healthcare innovation forward! About the Business: Oracle's Healthcare and Life Sciences division is at the forefront of delivering customized software and solutions for healthcare providers, payers, pharmaceutical companies, medical device firms, and clinical research organizations. Our offerings include state-of-the-art AI/ML solutions, cloud platforms, data analytics, electronic health records (EHR), and patient engagement systems. Our mission is to enhance patient outcomes, lower costs, and drive innovation, empowering organizations to leverage data for informed decision-making while ensuring compliance with strict healthcare regulations. What You'll Do: Collaborate closely with Oracle's product engineering teams to evaluate product functionality and develop effective regulatory strategies. Work across various disciplines 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, ensuring compliance with regulatory standards. Maintain thorough documentation and conduct ongoing post-market surveillance to uphold market authorization. Support internal and external audits, focusing on identifying, evaluating, and addressing risks and deficiencies. Serve as a subject matter expert for internal teams on standards and regulations, facilitating the implementation of our quality management system. Oversee compliance-related initiatives for health products. Review and recommend modifications to labeling, marketing communications, clinical protocols, design processes, and manufacturing procedures to ensure regulatory and quality compliance. Stay informed about evolving regulatory requirements that may impact our business and regulatory affairs functions. Preferred Qualifications: A Bachelor's degree or advanced degree is preferred. Proven experience in regulatory affairs, quality compliance, or product development for Software as a Medical Device (SaMD) is vital, showcasing a strong history of authoring submissions (e.g., 510(k), EU Technical Files). Familiarity with notified bodies and/or regulatory authorities is a plus. Able to thrive in a fast-paced, dynamic environment. Relevant certifications such as RAC, CQE, CPPS, CQA are advantageous. Experience with quality management systems, preferably with ISO 13485, ISO 14971, 60601, or related regulations. Strong understanding of continuous improvement and risk management principles, along with exceptional communication skills. Willingness to adapt to shifting priorities in a dynamic work environment. Disclaimer: Certain roles may require compliance with applicable health mandates. Salary and Benefits: The salary range for this role in the US is $87,000 to $178,100 annually, plus potential bonuses and equity. Oracle provides a comprehensive benefits package that includes medical, dental, and vision insurance, short- and long-term disability, life insurance, 401(k) plans with company matches, flexible vacation, 11 paid holidays, paid sick leave, parental leave, and more. This role will involve frequent interaction with global colleagues, thus proficiency in English is essential; knowledge of French is an asset. Oracle is committed to fostering a diverse and inclusive workforce that reflects the communities we serve, empowering every individual to make a difference. We encourage candidates from all backgrounds to apply.

Created: 2026-03-12