5 Fda Submissions Jobs

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5.0 - 9.0 years

0 Lacs

thane, maharashtra

On-site

As a skilled and proactive Medical Device Cybersecurity Engineer, you will play a critical role in ensuring the cybersecurity and regulatory compliance of connected medical devices throughout the product lifecycle. Your responsibilities will include: - Performing and maintaining comprehensive threat modeling (e.g., STRIDE) for embedded and connected medical devices. - Conducting regular vulnerability scans, penetration testing, and static/dynamic analysis using tools such as Kali Linux, Metasploit, Wireshark, NMAP, Fortify, Nessus, or similar. - Developing and updating cybersecurity risk assessments as part of the overall risk management process (including CVSS scoring). - Defining, implemen...

Posted 3 weeks ago

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1.0 - 5.0 years

0 Lacs

navi mumbai, maharashtra

On-site

Role Overview: As a RA Associate I at the company, you will be responsible for preparing and revising high-quality US Gx labeling documents filed under an ANDA and/or 505(b)2. You will ensure adherence to federal regulations and meet deadlines to align with company goals. Your role will involve developing compliant Structured Product Labeling (SPLs) files with complete drug listing information. Key Responsibilities: - Develop US labeling documents for assigned ANDAs and/or 505(b)(2)s, ensuring alignment with company goals and submission requirements while meeting all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents. - Establish SPL for assig...

Posted 3 weeks ago

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8.0 - 13.0 years

0 Lacs

karnataka

On-site

As a technical expert at Dexcom Corporation, you will be responsible for leading a team of software engineers to develop solutions for the continuous glucose monitoring (CGM) ecosystem. Your role will involve optimizing engineering systems and processes to ensure efficiency and high-quality output. Collaboration with architecture teams to drive the design and implementation of robust software solutions will be a key aspect of your work. You will also integrate cutting-edge tooling, including AI, into the development lifecycle to enhance productivity and innovation. Effective collaboration with cross-functional teams, such as product management, regulatory, and quality assurance, will be cruc...

Posted 1 month ago

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15.0 - 17.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Job Description Core Skills 15+ years of hands-on software development experience, with 3-5 years in a senior/principal architect role. Proven expertise in C# .NET and/or Java. Flexibility to work across both technologies is strongly preferred. Solid experience in backend architecture including system design patterns, cloud infrastructure, scalability, and reliability. Proficient in cloud-native architectures using AWS (preferred). Experience with Azure or GCP is a plus. Strong foundation in software design principles, design patterns, and clean architecture. Demonstrated experience designing and implementing complex, multi-generation software products. Deep understanding of Healthcare softw...

Posted 2 months ago

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5.0 - 13.0 years

0 Lacs

karnataka

On-site

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), with a vision to revolutionize diabetes management and improve health outcomes. With a history of 25 years in the industry, Dexcom is committed to empowering individuals to take control of their health by providing personalized insights to address significant health challenges. As we expand our focus beyond diabetes, our goal is to develop solutions for various health conditions and become a leading consumer health technology company through innovative biosensing technology experiences. As a Senior Software Engineer at Dexcom, you will play a key role in leading a team of software engineers to develop s...

Posted 3 months ago

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