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Experience Level
Experience
Qualifications
Proven experience in virtualization technologies such as VMware, Hyper-V, or similar platforms. Strong knowledge of server administration, including Windows and Linux environments. Ability to troubleshoot and resolve complex technical issues effectively. Familiarity with cloud computing and virtualization best practices. Excellent communication and teamwork skills. Relevant certifications (e.g., VMware Certified Professional, Microsoft Certified: Azure Administrator) are a plus.
About the job
Join our dynamic team at Integrated Resources, Inc. as a Virtualization and Server Administration Specialist. In this role, you will be responsible for managing and optimizing our virtualization infrastructure, ensuring high availability and performance of our server systems. You will work closely with cross-functional teams to implement best practices and enhance our server management processes. This is an excellent opportunity for individuals passionate about technology and eager to make a significant impact in a collaborative environment.
About Integrated Resources, Inc.
Integrated Resources, Inc. is a leading provider of technology solutions, dedicated to helping organizations streamline their operations through innovative IT services. Our commitment to excellence and employee development makes us a great place to grow your career.
Join our dynamic team at Integrated Resources, Inc. as a Virtualization and Server Administration Specialist. In this role, you will be responsible for managing and optimizing our virtualization infrastructure, ensuring high availability and performance of our server systems. You will work closely with cross-functional teams to implement best practices and e…
We are seeking a skilled SAP Infrastructure Specialist to join our team in Bridgewater, NJ. In this full-time permanent role, you will be responsible for designing and reviewing architecture solutions tailored to meet the infrastructure demands of SAP Business Suite on HANA and S/4. Your expertise will be vital in testing newly implemented systems and features, ensuring they align with organizational needs.Your responsibilities will include providing recommendations on hardware products and the optimal use of Cloud, Hosting, and On-Premise solutions. Collaborating with team members, you will help develop technology standards for PVH, focusing on selected SAP Applications to foster organizational growth and influence our future IT footprint.You will oversee quality assurance of architectural artifacts, including change management, refresh strategies, maintenance strategies, and upgrade schedules, all while adhering to established technical and documentation standards. Additionally, maintaining and operating the SAP landscape is critical to ensure 24/7 functionality with load balancing.Minimizing technical exposure and risk on projects is essential, as is participating and providing feedback in Disaster Recovery activities. You will also set priorities and allocate resources efficiently within the IT infrastructure team.
We are seeking a talented and dynamic Communication Specialist to join our team at Integrated Resources, Inc. In this role, you will be responsible for developing and implementing effective communication strategies that engage our stakeholders and enhance our brand image. Your exceptional writing and interpersonal skills will be crucial in crafting messages that resonate with our audience.
Position OverviewJoin our dynamic Process Sciences team as a Cell Therapy Manufacturing Specialist during our Night Shift from 6 PM to 6 AM. We are looking for an enthusiastic and driven individual who will play a pivotal role in advancing our cutting-edge cell therapy manufacturing platform. This position focuses on supporting manufacturing processes and day-to-day laboratory operations.We value individuals who thrive in a fast-paced, mission-oriented environment and are ready to embrace a range of challenges as our company continues to expand.
We are seeking a dedicated and experienced Regulatory Affairs Specialist III to join our team in Bridgewater, NJ. In this pivotal role, you will be responsible for ensuring compliance with regulatory requirements and managing submissions to various health authorities.Your expertise will play a vital role in supporting the development and marketing of pharmaceutical products. You will collaborate with cross-functional teams to prepare and submit regulatory documents, analyze regulatory changes, and ensure adherence to industry standards.
Join our dynamic Operations team as a Manufacturing Support Services Specialist at Cellares in Bridgewater, NJ. In this vital role, you will play a key part in the advancement of our cutting-edge cell therapy manufacturing platform. Your primary responsibilities will involve supporting both manufacturing and daily warehouse operations, ensuring smooth and efficient processes. This is a hands-on position that will provide you with in-depth training alongside our Manufacturing and Warehouse Team.We are looking for candidates who thrive in a fast-paced, mission-driven environment and are eager to embrace a variety of challenges as our company continues to grow.
Join our dynamic team as a Regulatory Affairs Specialist-V and play a pivotal role in ensuring compliance with regulatory standards in the pharmaceutical industry. You will be responsible for managing regulatory submissions, liaising with regulatory agencies, and ensuring that our products meet all necessary guidelines.
About Spectrum VascularSpectrum Vascular is a pioneering medical device firm dedicated to enhancing vascular access and medication management. Our mission is to improve patient outcomes globally by equipping caregivers with high-quality, innovative products and exceptional customer service. Formed through the integration of a trusted portfolio of widely used products, innovation remains a strategic pillar of our journey. Our designs focus on delivering antimicrobial and antithrombogenic protection, catering to critical care and pediatric patient needs. This role offers a unique chance to join a dynamic team with established products and an entrepreneurial spirit.Role Overview:The Regulatory Affairs Specialist plays a crucial role in supporting global regulatory submissions and ensuring compliance for medical device products throughout their lifecycle. This position requires collaboration with Quality, Engineering, Clinical, and Manufacturing teams to effectively prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.Assist in the preparation, formatting, and compilation of regulatory submissions (e.g., FDA 510(k), EU MDR Technical Documentation, Health Canada, and other global filings).Maintain regulatory files, declarations of conformity, and device registrations.Respond to regulatory agency requests for additional information (AIs, deficiency letters, technical queries).Support U.S. and EU market approval processes, ensuring adherence to regulatory standards.Assist with post-market submissions (progress reports, annual reports, etc.).Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers.Communicate with distributors concerning information requests, regulatory inquiries, and support for regulatory filings.Compliance & Quality System SupportCollaborate with Quality Assurance to maintain compliance with relevant regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745.Participate in internal audits, management reviews, and preparations for external audits as necessary.
Join our dynamic team at Integrated Resources, Inc. as a Virtualization and Server Administration Specialist. In this role, you will be responsible for managing and optimizing our virtualization infrastructure, ensuring high availability and performance of our server systems. You will work closely with cross-functional teams to implement best practices and e…
We are seeking a skilled SAP Infrastructure Specialist to join our team in Bridgewater, NJ. In this full-time permanent role, you will be responsible for designing and reviewing architecture solutions tailored to meet the infrastructure demands of SAP Business Suite on HANA and S/4. Your expertise will be vital in testing newly implemented systems and features, ensuring they align with organizational needs.Your responsibilities will include providing recommendations on hardware products and the optimal use of Cloud, Hosting, and On-Premise solutions. Collaborating with team members, you will help develop technology standards for PVH, focusing on selected SAP Applications to foster organizational growth and influence our future IT footprint.You will oversee quality assurance of architectural artifacts, including change management, refresh strategies, maintenance strategies, and upgrade schedules, all while adhering to established technical and documentation standards. Additionally, maintaining and operating the SAP landscape is critical to ensure 24/7 functionality with load balancing.Minimizing technical exposure and risk on projects is essential, as is participating and providing feedback in Disaster Recovery activities. You will also set priorities and allocate resources efficiently within the IT infrastructure team.
We are seeking a talented and dynamic Communication Specialist to join our team at Integrated Resources, Inc. In this role, you will be responsible for developing and implementing effective communication strategies that engage our stakeholders and enhance our brand image. Your exceptional writing and interpersonal skills will be crucial in crafting messages that resonate with our audience.
Position OverviewJoin our dynamic Process Sciences team as a Cell Therapy Manufacturing Specialist during our Night Shift from 6 PM to 6 AM. We are looking for an enthusiastic and driven individual who will play a pivotal role in advancing our cutting-edge cell therapy manufacturing platform. This position focuses on supporting manufacturing processes and day-to-day laboratory operations.We value individuals who thrive in a fast-paced, mission-oriented environment and are ready to embrace a range of challenges as our company continues to expand.
We are seeking a dedicated and experienced Regulatory Affairs Specialist III to join our team in Bridgewater, NJ. In this pivotal role, you will be responsible for ensuring compliance with regulatory requirements and managing submissions to various health authorities.Your expertise will play a vital role in supporting the development and marketing of pharmaceutical products. You will collaborate with cross-functional teams to prepare and submit regulatory documents, analyze regulatory changes, and ensure adherence to industry standards.
Join our dynamic Operations team as a Manufacturing Support Services Specialist at Cellares in Bridgewater, NJ. In this vital role, you will play a key part in the advancement of our cutting-edge cell therapy manufacturing platform. Your primary responsibilities will involve supporting both manufacturing and daily warehouse operations, ensuring smooth and efficient processes. This is a hands-on position that will provide you with in-depth training alongside our Manufacturing and Warehouse Team.We are looking for candidates who thrive in a fast-paced, mission-driven environment and are eager to embrace a variety of challenges as our company continues to grow.
Join our dynamic team as a Regulatory Affairs Specialist-V and play a pivotal role in ensuring compliance with regulatory standards in the pharmaceutical industry. You will be responsible for managing regulatory submissions, liaising with regulatory agencies, and ensuring that our products meet all necessary guidelines.
About Spectrum VascularSpectrum Vascular is a pioneering medical device firm dedicated to enhancing vascular access and medication management. Our mission is to improve patient outcomes globally by equipping caregivers with high-quality, innovative products and exceptional customer service. Formed through the integration of a trusted portfolio of widely used products, innovation remains a strategic pillar of our journey. Our designs focus on delivering antimicrobial and antithrombogenic protection, catering to critical care and pediatric patient needs. This role offers a unique chance to join a dynamic team with established products and an entrepreneurial spirit.Role Overview:The Regulatory Affairs Specialist plays a crucial role in supporting global regulatory submissions and ensuring compliance for medical device products throughout their lifecycle. This position requires collaboration with Quality, Engineering, Clinical, and Manufacturing teams to effectively prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.Assist in the preparation, formatting, and compilation of regulatory submissions (e.g., FDA 510(k), EU MDR Technical Documentation, Health Canada, and other global filings).Maintain regulatory files, declarations of conformity, and device registrations.Respond to regulatory agency requests for additional information (AIs, deficiency letters, technical queries).Support U.S. and EU market approval processes, ensuring adherence to regulatory standards.Assist with post-market submissions (progress reports, annual reports, etc.).Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers.Communicate with distributors concerning information requests, regulatory inquiries, and support for regulatory filings.Compliance & Quality System SupportCollaborate with Quality Assurance to maintain compliance with relevant regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745.Participate in internal audits, management reviews, and preparations for external audits as necessary.
