Haven Mccall work email
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Haven Mccall personal email
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I have worked in the biologics, medical device, and drug industry for 24 years in the areas of product development, scientific and technical consulting, quality, regulatory, clinical research, and laboratory testing. In addition to my work experience, I teach graduate level courses about FDA regulations at Johns Hopkins University.I am passionate about the life science industry and grateful for wonderful people I have met throughout my career.
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FounderBlue Sky Bio LabsSalt Lake City, Ut, Us -
Co-Founder & CsoNovo Laboratories, Llc Jan 2020 - PresentNovo Laboratories is an innovator in the field of regenerative medicine. Since our inception in March 2020, we have been at the forefront of biologics, committed to exploring the vast potential of human cells and tissue products. Our foundation lies in the collective expertise of a diverse team of scientists, researchers, clinicians, and industry specialists, all united with a singular vision: to revolutionize the landscape of healthcare through regenerative therapies. -
Lecturer - Regulatory Science Graduate ProgramThe Johns Hopkins University 2018 - PresentBaltimore, Md, UsTeach graduate level courses with a focus on global medical device regulations for biotech products. -
Board MemberBioutah Oct 2023 - PresentSalt Lake City, Utah, UsBioUtah is an independent, non-profit trade association serving the life sciences community in the state of Utah. We are comprised of manufacturers and developers of medical devices, pharmaceuticals, diagnostics and biotechnology products as well as government, academic and health care institutions all focused on improving health and wellness through the delivery of innovative technologies and services. We are passionately focused on advancing and growing Utah’s life sciences industry and encourage collaboration and innovation amongst our members. -
Consultant - Quality / Regulatory / Clinical ResearchRegulatory Haven, Llc Jan 2002 - Mar 2024Salt Lake City, Utah, UsProvide regulatory and quality consulting services for medical devices with a focus on the following areas: US Agent representation, quality management system implementation, auditing, 510k submissions, ISO 13485 certification, CE mark, FDA 483 and Warning Letter remediation, developing global regulatory strategies, FDA establishment registration, FDA communication, quality program implementation, maintenance, auditing, GLP / GMP / processing / manufacturing establishment, product and process validation. -
FounderCanyon Labs Oct 2020 - Dec 2023Bluffdale, Utah, UsCanyon Labs performs laboratory testing, quality, regulatory, scientific & technical consulting for products regulated by the FDA. -
Vice President Quality, Regulatory & Canyon LabsUltradent Products, Inc. Apr 2019 - May 2023South Jordan, Ut, UsResponsible for ensuring regulatory requirements are effectively established and maintained in harmony with global regulations, standards and directives. Ensure compliance to global quality system regulations, standards, directives and requirements, including USA FDA, GMP, ISO 13485, MDSAP, EU MDD and MDR, Australia TGA, Brazil ANVISA, Canada - CMDCAS, Japan MHLW/PMDA, China, KFDA, etc. Maintains oversight of FDA and Notified Body inspections and audits. -
Vice President, Regulatory Affairs & Quality AssuranceMegadyne Medical Products Jan 2015 - Jun 2017Lead all aspects of regulatory affairs and quality assurance with emphasis on compliance to GMP requirements and ISO standards. Developed and implemented regulatory strategies and processes. Was responsible for 510k submissions, CE mark and international submissions, registrations and renewals for medical devices. Ensured compliance to FDA regulations, EU Medical Device Directive (MDD), Canadian Medical Device Directive and other regulatory agencies. Facilitated FDA, Notified Body and all other regulatory agency inspections and audits.
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Quality / Regulatory / ComplianceGe Healthcare 2009 - 2015Chicago, UsWorked within GE Healthcare's portfolio of healthcare consulting and support services. Was responsible for the execution of services that supported the quality, regulatory and medical strategy. Ensured program outputs were compliant with domestic regulations and international standards. -
Post Market Regulatory Affairs / Product Surveillance LeaderW. L. Gore & Associates 2001 - 2009Newark, Delaware, UsProduct surveillance of Class III medical devices, including cardiothoracic, interventional, endovascular and general surgical products. Led multiple teams with responsibilities for complaint handling, medical device reporting, vigilance reporting, risk management and device tracking.
Haven Mccall Skills
Haven Mccall Education Details
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University Of Southern CaliforniaRegulatory Science -
University Of Southern CaliforniaRegulatory Science
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Northern Arizona UniversityMasters In Business
Frequently Asked Questions about Haven Mccall
What company does Haven Mccall work for?
Haven Mccall works for Blue Sky Bio Labs
What is Haven Mccall's role at the current company?
Haven Mccall's current role is Founder.
What is Haven Mccall's email address?
Haven Mccall's email address is dr****@****ent.com
What schools did Haven Mccall attend?
Haven Mccall attended University Of Southern California, University Of Southern California, Northern Arizona University.
What skills is Haven Mccall known for?
Haven Mccall has skills like Fda, Quality Assurance, Quality System, Medical Devices, Iso 13485, Capa, Validation, Regulatory Affairs, Quality Management, Cross Functional Team Leadership, Six Sigma, Design Control.
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