Oracle, headquartered in Austin, Texas, is a global leader in computing solutions. The company specializes in database management systems, cloud-engineered systems, and enterprise
Medical Device Regulatory Affairs Strategist
Location
United States
Posted
8 days ago
Salary
$87K - $178.1K / year
Seniority
Mid Level
No structured requirement data.
Job Description
Medical Device Regulatory Affairs Strategist
Oracle
Role Description 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. - 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). - Help prepare the required documentation to register products in global markets where the products are sold. - 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. - Define 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. - 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. - Seek a regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence in their work. Position is opened at the principal level, for 10+ years of experience. One level lower (senior) and one level higher (lead) will also be considered. 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. - 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. - Ability to perform in a fast-paced and continually evolving business environment. Benefits - Competitive benefits that support our people with flexible medical, life insurance, and retirement options. - Encouragement for employees to give back to their communities through volunteer programs. Company Description 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.
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