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 Principal/Lead/Senior Regulatory Affairs Specialist, 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 JAPAC region 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. 

 

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.

 

 

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:

• • Bachelor’s degree in pharmacy, Biology, Biomedical Engineering, Engineering, Life Sciences, Health Sciences, or related fields. 

• • Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring submissions across assigned JAPAC market required. Experience with sustaining and new product development is ideal. 

• • Comprehensive knowledge of regulatory requirements and processes across JAPAC region, with demonstrated experience interpreting local regulations and supporting market access, lifecycle compliance, and health authority engagements. 

• • Strong problem-solving, planning, and organizational skills, with the ability to manage multiple priorities and work independently in a fast-paced, cross-cultural environment. 

• • Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 62304, 21 CFR parts 1000/1001,  

• • Understands continual improvement and risk management. Excellent written and verbal communication skills.  

• • Experience engaging with regional trade associations, industry groups, or regulatory forums. 

• • Ability to adjust and adapt to changing priorities in a dynamic environment.  

• • Ability to perform in a fast-paced and continually evolving business environment. 

• Partner with Oracle product engineering teams to assess product functionality and determine appropriate regulatory strategies for JAPAC markets.
• Develop, prepare, and manage regulatory submissions to health authorities across JAPAC, including PMDA in Japan, TGA in Australia, HSA in Singapore, CDSCO in India, and other applicable regulators.
• Ensure ongoing compliance with country-specific regulatory requirements, health authority expectations, and applicable global standards.
• Maintain regulatory documentation, technical files, submission records, and post-market surveillance documentation.
• Support post-market surveillance activities, including monitoring, reporting, and follow-up actions required to maintain regulatory compliance.
• Support internal and external audits by identifying, assessing, documenting, and helping remediate regulatory and quality-related risks, gaps, and deficiencies.
• Serve as a regulatory and quality subject matter expert for internal stakeholders, providing guidance on applicable standards, regulations, and use of the quality management system.
• Manage regulatory affairs and compliance projects related to health-related products, ensuring timely execution and alignment with business needs.
• Review labeling, marketing materials, clinical protocols, design processes, procedures, and related documentation to ensure regulatory and quality compliance.
• Monitor evolving regulatory requirements across JAPAC and other global markets, and assess their impact on Oracle’s products, regulatory affairs activities, and quality/compliance programs.
• Build and maintain effective working relationships with regulatory agencies, affiliates, product teams, legal, quality, engineering, and other cross-functional stakeholders.
• Support practical, aligned regulatory outcomes by balancing compliance requirements, product strategy, business priorities, and health authority expectations.

 

Career Level - IC4