Medical Device Regulatory Affairs Strategist– Health & Life Sciences Legal – Health & Life Scie[...]

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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 stay competitive, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws, regulations, and public policies across the globe. 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. We are seeking a regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence in their work.

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 enables secure and compliant handling of sensitive healthcare data, helping organizations meet regulatory requirements and protect patient privacy. Oracle focuses on digital transformation to empower the industry to embrace modern technologies and improve healthcare delivery.

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• Work closely with Oracle’s product engineering teams to assess product functionality and develop regulatory strategy.
  
• Collaborate cross-functionally 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 markets ensuring compliance with regulatory authorities.
  
• Maintain documentation and post-market surveillance reports 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 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 our business, regulatory affairs function, and quality/compliance programs.
  

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• 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 (510(k), EU Tech Files, etc.) required. Experience with sustaining and new product development is ideal.
  
• Experience interfacing with notified bodies and/or regulators preferred.
  
• Ability to perform in a fast-paced and evolving business environment.
  
• RAC, CQE, CPPS, CQA desired.
  
• Experience in working within a quality management system, preferably ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001, or Quality System Regulations.
  
• Understanding of continual improvement and risk management. Excellent written and verbal communication skills.
  
• Ability to adjust to changing priorities in a dynamic environment.
  

As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity. We’re committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open global opportunities with work-life balance, competitive benefits, and flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance, email or call +1 888 404 2494 in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, or protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Health Care Provider

Industries: IT Services and IT Consulting

Note: This description is focused on responsibilities and qualifications for the role; it does not include excess boilerplate or unrelated postings.