BioStem Technologies
IT MANAGER
BioStem Technologies, Fort Lauderdale, Florida, us, 33336
IT MANAGER
BioStem Technologies, a leading MedTech company specializing in regenerative therapies, is seeking an experienced IT Manager to oversee the company's IT infrastructure, systems security, and compliance activities. Headquartered in Pompano Beach, FL, BioStem is pioneering advancements in placental-derived allografts, including AmnioWrap2®, Vendaje®, Vendaje AC®, and Vendaje Optic®, for advanced wound care and other regenerative applications. As BioStem continues to expand its footprint in the MedTech space, this role is critical to ensuring our IT operations support both growth and regulatory compliance, particularly under FDA 21 CFR Part 11 and Sarbanes-Oxley (SOX) guidelines.
The ideal candidate will have a strong background in IT management within regulated industries, bringing expertise in cybersecurity, infrastructure management, and IT compliance specific to public company operations. This is an opportunity to make a direct impact on a growing MedTech leader that is shaping the future of wound care solutions.
Key Responsibilities:IT Strategy & Infrastructure Management:Develop and implement IT strategies that align with BioStem's mission of transforming wound care and regenerative medicine through products like Vendaje, Vendaje AC, Vendaje Optic, and AmnioWrap2.Manage and maintain the company's IT infrastructure, ensuring systems are secure, scalable, and compliant with industry regulations.Oversee hardware, software, and cloud services management, ensuring optimal performance and security.Compliance & Regulatory Management:Ensure compliance with FDA 21 CFR Part 11, particularly around electronic records and signatures, to support BioStem's proprietary BioREtain® process used in products like Vendaje® and AmnioWrap2®.Implement IT systems that comply with SOX and other public company regulatory requirements.Collaborate with Quality Assurance and Regulatory teams to ensure IT systems align with Good Manufacturing Practices (GMP) and support the manufacturing of BioStem's product portfolio.Cybersecurity & Data Protection:Lead the development of cybersecurity strategies to safeguard BioStem's proprietary technologies and sensitive patient data.Implement robust firewalls, antivirus, and data backup systems to ensure compliance with business continuity and disaster recovery plans.Continuously monitor and assess IT risks, implementing proactive measures to maintain system integrity.Public Company IT Compliance:Oversee IT controls and reporting to ensure compliance with SEC requirements, supporting transparency in financial disclosures.Manage the technical aspects of IT-related audits and ensure readiness for both internal and external regulatory inspections.Conduct risk assessments to address any vulnerabilities in IT systems that could impact compliance and reporting.Team Leadership & Vendor Management:Lead and mentor the IT team, ensuring alignment with BioStem's growth objectives.Manage vendor relationships for hardware, software, and third-party services, ensuring optimal pricing and service delivery.Drive collaboration between IT and other departments to ensure technology supports business operations effectively.Project Management:Plan and oversee IT projects that enhance BioStem's technological capabilities, from infrastructure upgrades to new software implementations.Ensure projects are delivered on time, within scope, and align with regulatory requirements.Training & Development:Develop and implement training programs to educate employees on IT best practices, security protocols, and compliance standards.Stay informed on emerging technologies and regulatory trends to keep BioStem's IT infrastructure cutting-edge and compliant.Requirements
Qualifications:
Education:Bachelor's degree in Information Technology, Computer Science, or a related field. A Master's degree is preferred.Experience:5-7 years of IT management experience in a highly regulated industry (e.g., MedTech, biotech, healthcare).Proven experience with FDA 21 CFR Part 11 and SOX compliance, particularly within public companies.Strong expertise in cybersecurity, particularly in protecting sensitive medical data and intellectual property.Certifications (Preferred):CISA, CISSP, PMP, or relevant certifications.Skills:Proven leadership skills with experience managing a diverse IT team.Extensive knowledge of IT systems, cloud platforms, and regulatory compliance.Strong problem-solving and decision-making abilities.Excellent communication skills to translate technical concepts for non-technical stakeholders.
BioStem Technologies, a leading MedTech company specializing in regenerative therapies, is seeking an experienced IT Manager to oversee the company's IT infrastructure, systems security, and compliance activities. Headquartered in Pompano Beach, FL, BioStem is pioneering advancements in placental-derived allografts, including AmnioWrap2®, Vendaje®, Vendaje AC®, and Vendaje Optic®, for advanced wound care and other regenerative applications. As BioStem continues to expand its footprint in the MedTech space, this role is critical to ensuring our IT operations support both growth and regulatory compliance, particularly under FDA 21 CFR Part 11 and Sarbanes-Oxley (SOX) guidelines.
The ideal candidate will have a strong background in IT management within regulated industries, bringing expertise in cybersecurity, infrastructure management, and IT compliance specific to public company operations. This is an opportunity to make a direct impact on a growing MedTech leader that is shaping the future of wound care solutions.
Key Responsibilities:IT Strategy & Infrastructure Management:Develop and implement IT strategies that align with BioStem's mission of transforming wound care and regenerative medicine through products like Vendaje, Vendaje AC, Vendaje Optic, and AmnioWrap2.Manage and maintain the company's IT infrastructure, ensuring systems are secure, scalable, and compliant with industry regulations.Oversee hardware, software, and cloud services management, ensuring optimal performance and security.Compliance & Regulatory Management:Ensure compliance with FDA 21 CFR Part 11, particularly around electronic records and signatures, to support BioStem's proprietary BioREtain® process used in products like Vendaje® and AmnioWrap2®.Implement IT systems that comply with SOX and other public company regulatory requirements.Collaborate with Quality Assurance and Regulatory teams to ensure IT systems align with Good Manufacturing Practices (GMP) and support the manufacturing of BioStem's product portfolio.Cybersecurity & Data Protection:Lead the development of cybersecurity strategies to safeguard BioStem's proprietary technologies and sensitive patient data.Implement robust firewalls, antivirus, and data backup systems to ensure compliance with business continuity and disaster recovery plans.Continuously monitor and assess IT risks, implementing proactive measures to maintain system integrity.Public Company IT Compliance:Oversee IT controls and reporting to ensure compliance with SEC requirements, supporting transparency in financial disclosures.Manage the technical aspects of IT-related audits and ensure readiness for both internal and external regulatory inspections.Conduct risk assessments to address any vulnerabilities in IT systems that could impact compliance and reporting.Team Leadership & Vendor Management:Lead and mentor the IT team, ensuring alignment with BioStem's growth objectives.Manage vendor relationships for hardware, software, and third-party services, ensuring optimal pricing and service delivery.Drive collaboration between IT and other departments to ensure technology supports business operations effectively.Project Management:Plan and oversee IT projects that enhance BioStem's technological capabilities, from infrastructure upgrades to new software implementations.Ensure projects are delivered on time, within scope, and align with regulatory requirements.Training & Development:Develop and implement training programs to educate employees on IT best practices, security protocols, and compliance standards.Stay informed on emerging technologies and regulatory trends to keep BioStem's IT infrastructure cutting-edge and compliant.Requirements
Qualifications:
Education:Bachelor's degree in Information Technology, Computer Science, or a related field. A Master's degree is preferred.Experience:5-7 years of IT management experience in a highly regulated industry (e.g., MedTech, biotech, healthcare).Proven experience with FDA 21 CFR Part 11 and SOX compliance, particularly within public companies.Strong expertise in cybersecurity, particularly in protecting sensitive medical data and intellectual property.Certifications (Preferred):CISA, CISSP, PMP, or relevant certifications.Skills:Proven leadership skills with experience managing a diverse IT team.Extensive knowledge of IT systems, cloud platforms, and regulatory compliance.Strong problem-solving and decision-making abilities.Excellent communication skills to translate technical concepts for non-technical stakeholders.