Claus Svane Søndergaard
Director @ MCRA, an IQVIA business
About
I bridge the gap between complex biomedical science and global regulatory clearance. With a PhD in Biomedicine and 17 years of cross-functional experience spanning academic research, medical device industry, and high-intensity consulting, I specialize in navigating the most technical aspects of medical device submissions such as ISO 10993 (Biocompatibility), ISO 18562 (Breathing Gas Pathways), as well as cleaning, packaging and sterilization validation. Strategic Impact & Throughput: In my current role as Director at MCRA, I operate at an executive cadence, supporting in excess of 150 regulatory projects annually for up to 15 diverse global clients on a weekly basis. I translate deep technical data into actionable regulatory strategies that move high-risk Class II and III devices through FDA and international pipelines. Regulatory Diplomacy: I serve as subject matter expert on behalf of client is FDA interactions, participating in formal meetings and pre-submissions on a regular basis. This has allowed me to build a nuanced understanding of current Agency expectations, particularly regarding the shifting expectations toward risk-based biological evaluation (BEP) and chemical characterization. Core Expertise: - Biocompatibility Strategy: Advanced implementation of ISO 10993 and ISO 18562 for medical devices and combination products. - Validation Leadership: SME in regulatory expectations for cleaning validation, packaging integrity, and sterilization (EO, Steam, Radiation). - Portfolio Management: Proven ability to manage high-volume technical budgets ($250k+) and high-value billable operations ($625k+ annual value). - Regenerative Medicine: Deep roots in bioscaffold development and cardiovascular repair. I am passionate about accelerating patient access to safe technologies by solving the "unsolvable" regulatory bottlenecks.
United States
West Lafayette
Management Consulting
Research Skills, ISO 10993, Regulatory Strategy Development, Medical Devices, Risk Assessment, Regulatory Submissions, Stem Cells, Cell, Molecular Biology, Cell Culture, Flow Cytometry, Life Sciences, Immunohistochemistry, Animal Models, Regenerative Medicine, Cell Based Assays, Biotechnology, Tissue Culture, Tissue Engineering, Stem Cell Research
Experience
Director
MCRA, an IQVIA business
United States
Associate Director
MCRA, an IQVIA business
United States
Senior Manager
MCRA, an IQVIA business
United States
Senior Manager - Biocompatibility • Developing and executing biocompatibility services for client companies: • Biological Evaluation Plans (BEP) and Reports (BER) • Biocompatibility sections in US regulatory submissions (510(k), IDE, PMA, IND, BLA, & IND) • Biocompatibility sections in International Regulatory Submissions (Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs)) • Biocompatibility Evaluation Strategy, Analysis & Development • Design, Review & Implement biocompatibility evaluations including biological testing, chemical characterization, and biological risk assessments • Toxicological risk assessments • Communicating with regulatory bodies and clients
Manager, Discovery & Biosciences
Evergen (Formerly Cook Biotech)
West Lafayette, IN
Manager for Department of Discovery and Biosciences: - 3200 sqf research lab - Biological and toxicological risk assessment unit, 100+ biocompatibility assessments, zoonotic surveillance reports, biological risk assessments for multiple products in development and currently on the market domestically and internationally - Lead author ISO22442 compliant zoonotic surveillance reports and viral inactivation validation studies - Technology review program for internal and extern novel technologies - Multidisciplinary research team with 100+ internally filed research study reports - Shared laboratory services for local CRO specializing in in vitro pre-clinical testing service - Implemented ELN system - IP, patents, including HTC/p regenerative medicine product currently on the market - Early development projects for regenerative medical devices - Academic research collaborations, including one in pre-IND stage and one in the clinic - Cross organizational development programs
Manager, Scientific Research and Testing
Evergen (Formerly Cook Biotech)
West Lafayette, IN
Manager for discovery research, medical device testing, preclinical testing, biocompatibility, academic research collaborations. Member of: Cook Medical Global Discovery Group Cook Biotech CAPA Review Board
Assistant Adjunct Professor
UC Davis Medical Center
Department of Surgery
Assistant Adjunct Professor - Project director for a $4.63 million pre-clinical translational research project sponsored by the State of California (California Institute for Regenerative Medicine) - Single point of contact for all internal and external stakeholders; 15+ UC Davis researchers, the US Airforce, CIRM and key industry partners (Saint-Gobain, Cook Group) - Developed and implemented of multifaceted project plans, including resource allocation, project deliverables, budgets, and milestones - Timely reported all internal and external deliverables to stakeholders - Established and managing a state of the art bioengineering laboratory - Proactively identifying and communicate project deviations; timelines, budgets and deliverables - Lead efforts for next level funding efforts with private, state, and federal funding agencies - Early engagement FDA - Co-authored and secured a $1.83 million technology development grant as co-investigator - Developed novel devices and engineering solutions with internal and external partners for GMP compliant stem cell culture at scale - Consultant to research teams developing regenerative cures using adult and neonatal stem cells - Completed comprehensive leadership training program at top ranking US University - Teaching and mentoring of student and staff
Visiting Assistant Professor
UC Davis Medical Center
Department of Surgery
Project director: Tissue engineering project targeting heart disease
Post Doctoral Scholar
UC Davis Medical Center
Stem cell research, cell based regenerative medicine and tissue engineering with special focus on heart disease and peripheral vascular disease.
Research Assistant
Aarhus University
Aarhus, Denmark
Lab manager at the Department of Molecular and Structural Biology, Dr. Lene Perdersen group.
Research scholar
Washington University School of Medicine in St. Louis
Research scholar in the laboratory of associate professor Jan Nolta, PhD. Working on tracing of human stem and progenitor cells in immune defect murine models of acute myocardial infarction by nanoparticle labelling and evaluation of regeneration potential of infracted tissue in the same model.
Research assistant
Aarhus University
Research assistant to associate professor Lene Pedersen, PhD. Concluding undergraduate work on preclinical models of retroviral gene therapy.
Education
Aarhus University
Medicine
PhD project on pre-clinical animal models for hematopoietic stem cell regeneration of tissue damage - specifically in models for acute myocardial infarction in immune defect rodents.
UW Foster School of Business
Project Management
- Project Management Standards & Processes - Project Management within a Biotech/Research Environment - Applying Project Management Principles to Biomedical & Pharmaceutical Product Development - Biotechnology Project Capstone
Aarhus University
Biology and Molecular biology
Claus Svane Søndergaard's Contact Information
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