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Carolyn Glickman

Experienced Quality and Regulatory Leader

Professional Background

Carolyn Glickman is a seasoned Quality and Regulatory Professional with extensive expertise in Regulatory Affairs, Quality Operations, Development, and Systems, specifically within the realms of medical devices, biologics, and clinical laboratories. Her career has been marked by a dedication to ensuring compliance and high standards in quality, making her a vital asset in the technical operations environment. With a robust track record in problem-solving, Carolyn excels in overseeing processes that enhance product quality and regulatory compliance.

Throughout her impressive career, Carolyn has held significant leadership roles, including her current position as the Director of Regulatory Affairs at Roche. In this role, she deftly navigates the complex regulatory environment, ensuring that products meet stringent guidelines and maintain the highest integrity and safety standards for consumers. Before joining Roche, Carolyn served as the Director of Quality and Regulatory at Visby Medical, where she successfully led initiatives to improve quality systems and regulatory compliance, demonstrating her capacity to drive impactful change in an organization. Her prior experiences include critical positions such as Senior QA Specialist at Genomic Health, Senior Manager of Quality Engineering at Complete Genomics Inc., and Principal Engineer at Baxter BioScience.

Carolyn is highly regarded in her field for her ability to lead Quality Assurance and Quality Control laboratory functions while also overseeing Regulatory functions. Her multi-faceted approach to quality and regulatory challenges has established her as a thought leader in the industry, equipped to address the evolving landscape of regulations and compliance standards.

Education and Achievements

Carolyn Glickman's academic journey laid the foundation for her successful career in the biomedical and chemical engineering fields. She earned her Bachelor of Science in Biomedical Engineering from The Johns Hopkins University, a prestigious institution known for its rigorous engineering programs and innovative research initiatives. This educational background provided Carolyn with a robust understanding of the technical aspects of medical devices and healthcare applications.

Following her undergraduate studies, Carolyn pursued a Master of Science in Chemical Engineering at the University of California, Los Angeles (UCLA). This advanced education has equipped her with specialized knowledge in chemical processes and product development, further enhancing her contributions to quality operations and regulatory affairs in her subsequent professional roles.

Among her numerous professional accomplishments, Carolyn has achieved significant certifications and accreditations that underscore her expertise in the field. Notably, she successfully led initiatives to achieve ISO 13485:2016 certification, California FDB licensure, and ISO 17025 accreditation for her organizations, showcasing her proficiency in preparing companies to meet international quality management system standards.

Achievements

Carolyn's achievements in the quality and regulatory landscape are remarkable, with a strong focus on compliance and operational excellence. She has authored FDA pre-submissions and played a pivotal role in securing dual 510(k) and CLIA Waiver submissions, as well as applying for laboratory developed test (LDT) applications to New York State. These contributions highlight her deep understanding of regulatory processes and her ability to meet complex requirements.

Her technical aptitude is further illustrated by her hands-on experience as a technical manager, where she has successfully facilitated operations compliant with ISO 14971 and IEC 62304 standards. Carolyn's leadership in guiding Quality Assurance and Quality Control functions emphasizes her unique knack for troubleshooting and finding innovative solutions to regulatory and quality-related challenges, ensuring the safety and efficacy of medical devices and diagnostic tests.

Over the years, Carolyn Glickman has established herself as a key player in the regulatory affairs sector, contributing her expertise and insights to the growth and compliance of medical technologies and healthcare solutions. With a commitment to excellence, Carolyn continues to influence the field and advance the quality and regulatory practices within the biomedical and clinical laboratory arenas.

Related Questions

How did Carolyn Glickman achieve ISO 13485:2016 certification and what impact did it have on her organization?
What strategies did Carolyn Glickman employ to successfully lead Quality Assurance and Regulatory functions at Roche?
Can Carolyn Glickman share insights into the process of authoring FDA pre-submissions and securing regulatory approvals?
What challenges has Carolyn Glickman faced in the medical device sector and how has she overcome them?
How has Carolyn Glickman's education in Biomedical Engineering and Chemical Engineering contributed to her success in regulatory affairs?
Carolyn Glickman
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Location

Mountain View, California, United States