Regulatory Affairs professional with 20+ years of experience in the medical device industry, in various quality and regulatory roles for ventilation, IVD, and infusion devices. Strong knowledge of quality system regulations/standards (21CFR, ISO 13485). Author of 510(k)s, Licence Amendments and Technical Files resulting in multiple clearances and registrations.
Leica Biosystems
View- Website:
- leicabiosystems.com
- Employees:
- 2458
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Regulatory Affairs Principal IiLeica BiosystemsApex, Nc, Us
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Sr Staff Regulatory Affairs SpecialistLeica Biosystems May 2021 - PresentSupport projects for artificial intelligence and assay development. Participate in various trade associations. Established Regulatory Intelligence process. Create and execute regulatory strategies. Author of 513(g) Submissions. Experience with FDA CCP. Manage backroom for internal and external audits.
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Sr Lead Regulatory AffairsAccriva Diagnostics Nov 2020 - May 2021Regulatory Lead on IVDR and new product development projects for automated platelet aggregation systems. Reviewed and approved design planning and input documents. Developed system level Regulatory Strategy. Created IVDR technical document. -
Staff Regulatory Affairs SpecialistBd Oct 2018 - Nov 2020Conduct gap assessments for new and revised guidance documents and regulations on ongoing projects, legacy products, and the quality system. Developed and executed global, multi-platform and multi-device regulatory strategies. Created template for 510(k) SE Section. Author of Q-Submissions. -
Regulatory Management AdvisorBd Mar 2014 - Oct 2018Greater San Diego AreaRegulatory Lead for infusion system, standalone software, and embedded software projects. Member of Internal Audit Team, Risk assessment Board, and Software Anomaly Review Board. Managed backroom during external agency inspections. AdvaMed Software Working Group participant. Responded to elements of agency deficiency letters FDA 510(k) AIR response (K133532), FDA RTA response, and Canadian Licence Application (224078).
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Regulatory Affairs Project ManagerAlere Inc. Apr 2011 - Mar 2014Greater San Diego AreaProvided regulatory support for IVD, instrumentation, and software projects. Classification standalone software applications. Participated in the development of compliant software quality systems procedures. Responded to software related submission deficiencies for FDA 510(k) AIR response (K110212) and Submission (K120615). -
Regulatory Affairs SpecialistPhilips Oct 2008 - Apr 2011Carlsbad, CaDeveloped and executed regulatory strategies resulting in the submission and clearance of 510(k)s (K102054, K102985, K110083). Managed backroom during FDA inspection. Managed front room during ANVISA and notified body inspections. Reviewed and approved labels, labeling, design changes, and manufacturing changes. -
Regulatory Compliance SpecialistPhilips Apr 2006 - Oct 2008Carlsbad, CaManaged internal audit and training programs. Participated in external agency inspections. Regulatory lead for quality systems improvement initiatives. Revamped internal training profiles.
Tammy M. Education Details
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Ucsd ExtensionRegulatory Affairs For Biomedical Industry -
PalomarQuality Assurance Technology
Frequently Asked Questions about Tammy M.
What company does Tammy M. work for?
Tammy M. works for Leica Biosystems
What is Tammy M.'s role at the current company?
Tammy M.'s current role is Regulatory Affairs Principal II.
What schools did Tammy M. attend?
Tammy M. attended Ucsd Extension, Palomar.
Who are Tammy M.'s colleagues?
Tammy M.'s colleagues are Julia Luciano-Chadee, Chetan Shet, Raphael Myant, Bryce Brown, Shrigowri Hiraskar, Jonas Reckel, Joana Silva.
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