Regulatory Affairs Post Market Specialist - Health & Life Sciences Legal
Location: Remote/telecommuting from within the US
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.
The Regulatory Affairs Post Market Specialist supports the ongoing monitoring, evaluation, documentation, and escalation of product performance and safety information after launch. This role helps ensure that post-market signals are captured, assessed, and tracked, in accordance with regulatory requirements and internal procedures as part of the quality system. This role will manage and coordinate analysis of post-market product feedback, complaints, adverse events, incidents, field reports, and other safety or performance issues for trend analysis and PMS reporting obligations. The Post-Market Surveillance Coordinator will lead a review of post-market surveillance processes and drive continual process improvement to maintain compliance to global market requirements.
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 Affairs Post Market Surveillance Specialist 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.
Preferred Qualifications:
• BA/BS or advanced degree preferred
• 6+ years' experience in quality systems, post-market signaling, real world evidence tracking, regulatory reporting (or 4+ years with Master's)
• Experience authoring submissions (510k, EU Technical Documentation, etc.) required
• Experience leading process development
• Experience acting as a lead to resolve issues
• Demonstrated critical thinking skills focused on improved system performance outcomes and positive impact
• Excellent problem-solving skills; demonstrated application of structured problem-solving methods and tools
• Expertise in continual improvement and risk management
• Experience with advanced root cause analysis methods
• Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent
• Experience with sustaining and new product development is ideal
• Experience interacting with regulators preferred
• RAC, CQE, CPPS, or CQA certifications desired
• Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, IEC 62304, 21 CFR parts 210, 211, 803, 820, or other quality system regulations
• Excellent written and verbal communication skills
• 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
What You'll Do:
• Manage and contribute to the process design of post market surveillance activities
• Post market surveillance processes and activities related to product performance monitoring and reporting to meet medical device post-market requirements at all phases of the device lifecycle
• Support clinical evaluation and post‑market surveillance processes through systematic literature surveillance, post‑market data review, and integration of PMCF/Real World data into clinical evaluations, risk management files, and regulatory submissions
• Design cross-functional processes to generate safety and performance data to identify trends and early-warning signals in support of post-market activities
• Drive continual improvement activities and support quality processes to ensure compliance with all applicable regulations and requirements
• Collaborate with business partners to share feedback in order to improve product performance
• Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions as required
• Initiate and facilitate corrective or preventative actions as needed
• Enable compliant quality and regulatory communications for current products
• Support and participate in internal and external audits, risk management activities, and continual improvement
• Prepare and provide monthly reports to trend key quality measures as part of the post-market surveillance system
• Provide expertise to and coordinate across Quality, Marketing, Product Development, Clinical, and Regulatory staff in support of a robust post market surveillance system
Required Skills
• Continuous Improvement
• Quality Management
• Regulatory Audits
• Regulatory Oversight
• Regulatory Reporting
• Regulatory Submissions
• Risk Management
• Technical Communication