Regulatory Affairs Manager

Start your journey of growth and success with us, making your mark and creating a lasting impact on your career. At TRIPLECOM, we believe that our success is driven by the talent, dedication, and passion of our team members. We are always on the lookout for exceptional individuals who share our vision and are eager to make a positive impact in the industry we operate in. Working at TRIPLECOM means being part of a dynamic and innovative team that is committed to excellence. We foster a collaborative and inclusive work environment that values diversity and encourages personal and professional growth. As a member of our team, you will have the opportunity to work on exciting projects and contribute to cutting‑edge advancements in industry. We believe in providing our employees with the tools, resources, and support they need to thrive and succeed. Your ideas and contributions will be valued, and you will have the autonomy to make a meaningful difference. At TRIPLECOM, we are committed to fostering a culture of continuous learning and development. We provide ongoing training opportunities, mentorship programs, and access to the latest industry trends and technologies. We believe in empowering our employees to reach their full potential and achieve their career goals. If you are a talented professional with expertise in the respective fields and a passion for creating innovative solutions, we invite you to apply for these exciting positions. Join our dynamic team at TRIPLECOM as we strive to make a significant impact in the industry with new technology and services. If you are passionate and want to be part of a dynamic team that is making a difference, we invite you to explore our current career opportunities. Whether you are an experienced professional or just starting your career journey, we have positions that may be the perfect fit for you. Job Listing Azure Data Engineer – Eatontown, NJ Build Data Ingestion Pipelines for Data Migration using Azure Data Factory or Synapse Pipelines to orchestrate migration from various sources to a target location. Perform ETL or ELT based on data requirements. Sources include Relational Databases such as Oracle, MS SQL Server, PostgreSQL or files (CSV, JSON, XML) and REST APIs. Build a Data Warehouse Solution on Microsoft Fabric Platform and migrate all objects and data. Choose a Synapse Distribution Strategy based on tables categorized as facts or dimensions. Build processes to support both batch and streaming data using Synapse Real Time Analytics for streams and ADF for batch loads. Build data processing flows (ad‑hoc processes) to ensure data validation across systems, data quality, and data governance for proper access. Build reports and dashboards for business insights, KPIs and performance reporting. Work with cross‑platform teams, Data Architects, Technical Managers and stakeholders. Support downstream applications. Resolve production issues. Gather updated requirements, design, develop, and deploy solutions recursively under the supervision of architects or technical managers. Qualifications: Bachelor’s Degree required in Computer Science, Computer Engineering, Information Technology or a related field. Database Administrator – Eatontown, NJ Lead data migration activities including mapping, transformation and validation in Oracle Fusion Cloud. Provide techno‑functional support for Oracle Fusion applications, addressing both technical configurations and business process requirements. Design and build custom reports using Oracle BI Publisher, OTBI and other reporting tools. Integrate Oracle Fusion with other systems using Oracle Integration Cloud or other middleware. Gather, analyze and document requirements. Conduct UAT, data validation and system testing. Maintain documentation of data conversion processes, configuration settings and reporting standards. Other related duties as assigned. Bachelor’s Degree required in Computer Science, Applied Computer Science, Information Technology or Information Systems. Systems Engineer – Eatontown, NJ Design and develop solutions to complex application problems, system administration issues, or network concerns. Develop BI solutions using Microsoft Power Platform (Power BI, Power Apps, Power Automate). Develop Azure‑based reports, dataflows, dashboards and datasets. Assist in systems planning, business information analysis and process improvement initiatives. Automate report deployment to SharePoint using PowerShell. Debug and resolve data warehousing issues ensuring compliance with data quality standards. Develop and implement data security protocols. Perform systems management and provide technical leadership in fully integrated technology solutions. Document and communicate technical details and test procedures. Develop reusable components and services. Conduct data analysis to translate business needs into optimized database designs. Plan, test, integrate, deploy and sustain technical solutions. Establish metadata management covering unified data catalog, lineage and classification. Process reports and monitor system performance. Maintain excellent communication and vendor experience. Proficient in SDLC, Agile, DevOps and QA lifecycle. Implement data quality procedures and validation. Establish and document quality control procedures. Manage schedules, processing and distribution of reports. Troubleshoot systems and applications. Ensure compliance with regulatory reporting requirements such as GDPR and CCPA. Implement AI tools such as Copilot into BI and governance. Bachelor's Degree required in Computer Science, Computer Engineering, Computer Information Systems or Applied Computer Science. Quality Assurance Engineer – Eatontown, NJ Establish and maintain a master validation program, including site and individual product and process master validations. Create, review, support validation protocols and reports to aid process and reliability improvements. Support complaint handling program including analysis, investigation and follow‑up. Lead or support reliability and process improvement projects from a quality perspective. Establish and maintain process controls and SPC for specific production processes. Support corrective and preventive action (CAPA) program. Review and modify product designs and process documentation for quality characteristics such as manufacturability, serviceability, testability, reliability and conformance to product and quality system requirements. Demonstrate product compliance for sterilization, biocompatibility, package integrity, shelf life, reliability and electrical safety. Review and provide feedback on protocols and reports, vendor qualification and testing management. Assist with development and maintenance of product risk management files. Recommend requirements for first article inspection, incoming and in‑process inspections, and lot release testing, including sampling strategy and test methods. Participate in failure investigations to analyze internal system or process failures and implement corrective and preventive action. Participate in component and service new supplier evaluation and ensure appropriate quality controls by suppliers. Audit Design History Files and resolve documentation issues with cross‑functional teams. Identify and implement good quality engineering practices, including statistical methods and root cause analysis tools. Participate in supplier material‑related processes including coordination of MRB activities. Support continuous product and process improvement through detailed failure analysis for non‑conformances and implement effective, compliant solutions. Demonstrate the ability to implement ISO14971 and other risk evaluation techniques. Equipment Validation Engineer – Norwood, MA Work will be 100% on‑site. Responsibilities include re‑qualification and re‑validation of equipment, IQ, OQ and PQ process support, protocol writing, protocol reporting, and execution. Must be well‑versed in IQ, OQ, and PQ, and have medical device experience; catheter experience is a plus. Duration: 3‑4 months contract. Interview: telephonic and Webex. Contractor Engineer – Pleasanton, CA Project work for combination medical devices. Activities include contributing to product design documentation, conducting laboratory studies of product performance, and supporting product development, manufacturing transfers, investigations and product enhancements. Work conducted in compliance with device design controls (FDA21CFR820.30 and/or ISO13485). Requires mechanical design and drawing proficiency, CAD (Creo or SolidWorks), and plastic design experience. Preference for candidates with Masters and mechanical engineering background. Responsibilities include CAD data model generation, prototype building, laboratory work, data analysis, and reporting. Compliance with regulatory reporting requirements including GDPR and CCPA. The role is a six‑month contract. Qualifications: Bachelor's Degree or equivalent in Mechanical or related field with 5+ years of experience. Other Skills: CAD experience (Creo or SolidWorks) and plastic design. Tolerance analysis, product design prototyping and testing experience. #J-18808-Ljbffr