Michael Siano Email and Phone Number
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Regulatory affairs professional with background in biotech R & D, software development, technical writing, and project management. Over 100 successful submissions to US FDA, EU Notified Bodies, Health Canada, and international regulatory authorities. US FDA experience includes 510(k), 513(g), and Q-Sub submissions, device classification and predicate selection, identification of applicable standards and testing, and leading meetings and interactions with US FDA.EU experience includes Technical File/Documentation preparation (MDD & MDR), Clinical Evaluation Reports (CERs), Risk Management according to ISO 14971, device classifications, labeling compliance, and regulatory strategy.International work in regulatory strategy, product assessment, device classification, labeling, device registrations, and post-market activities; regulatory planning and execution of mergers and acquisitions.Experience with various product types, including SaMDs (wearables, smartphone apps, AI/AR), IVDs, implantable devices, and active devices.
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Regulatory ManagerCardiosense Feb 2024 - PresentChicago, Illinois, Us
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Senior Program Manager, RaEnovis Jul 2021 - Nov 2023Wilmington, Delaware, UsResponsible for all aspects of regulatory compliance for new product development and sustaining products.- Advise cross-functional teams through all stages of product development- Prepare and submit regulatory submissions for US, EU, and international market-authorizations- Liaise with regulatory authorities on behalf of company- Provide regulatory review of labeling, marketing material, etc.- Own CAPAs through life-cycle- Review and assess all changes to device design, manufacturing processes, and labeling- Collaborate on development and improvement of internal procedures and systems -
Senior Regulatory ConsultantEmergo By Ul Apr 2020 - Jul 2021Austin, Tx, UsPerform consulting across various product types, including orthopedics, SaMDs, IVDs, implantable, and active devices. Contribute to development and maintenance of internal processes and procedures.• Provide consulting in:- EU (MDD and MDR), US, Canada, and international regulatory affairs- International strategy in market-entry, labeling, product positioning, etc. - Risk Management, Clinical Evaluation, and performance testing- EU Technical File/Documentation compilation - International registrations, renewals, change notifications, post-market vigilance- US FDA 510(k)s, 513(g)s, Pre-Submissions, device classification, predicate identification, labelling, etc.• Support and train new/junior staff• Support internal quality system; contribute to process development and SOPs -
Regulatory Affairs ConsultantEmergo By Ul Aug 2018 - Apr 2020Austin, Tx, UsProvide regulatory consulting to medical device manufacturers in US, EU, and international regulatory affairs, including product classifications and positioning, market authorizations, labeling, and change assessment. Contribute to development of internal processes and procedures. Train and mentor junior staff.
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Senior Global Regulatory SpecialistEmergo By Ul Oct 2010 - Aug 2018Austin, Tx, Us• Provide consulting in:- Global regulatory strategy and market-entry- EU Technical Files (Risk Management, Clinical Evaluation Reports, etc.)- International medical device registrations, labeling & promotion, and change notifications• Monitor global regulatory updates and maintain regulatory intelligence database• Manage small team of associates
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Advisor, Workspaces @ Texas Health ColabDell Medical School At The University Of Texas At Austin 2019 - 2020Austin, Tx, UsAdvised early-stage medical device startup companies on regulatory strategy, product classification, and quality system development. -
Software Developer/Technical WriterCompeat Restaurant Management Systems Feb 2007 - Aug 2010Austin, Texas, UsResponsible for authoring, maintaining, and managing user documentation. Contribute software development including UI design in Windows Forms, database and stored procedures in SQL Server, and logic in C#.• Develop features and fix bugs in Windows Forms/C#/.NET• Perform miscellaneous web development in ASP.NET/C#• Write queries, stored procedures, and functions in SQL/SSMS• Design and perform software QA/testing• Write and maintain software documentation -
Product OwnerSapling Systems Aug 2005 - Feb 2007Responsible for obtaining development input requirements from internal and external stakeholders, preparing specifications, prioritizing tasks for development cycle, and performing validation of new features. Responsible for development and maintenance of software documentation.• Plan and schedule software development work using Agile process• Write and execute test cases for software validation• Manage and maintain software documentation
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Freelance WriterVarious Dec 2004 - Aug 2005• Work with clients to determine project requirements, timelines, and outputs.• Author various works in science education (textbook sections, end of chapter quizzes, etc.)
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Scientific EditorAmbion, Inc. Jul 2003 - Dec 2004UsResponsible for preparing and maintaining product manuals, specifications sheets, and catalogs. Contribute to company newsletter, brochures, and other promotional material.• Work with R & D to prepare manuals and spec sheets for new products.• Maintain existing manuals and spec sheets, and revise for product changes.• Collaborate with Marketing to produce promotional and educational content.• Write/edit technical documentation (manuals, spec sheets, catalogs, etc.) -
Research Associate IiAmbion, Inc. Mar 2002 - Jun 2003UsDevelop kits for RNA extraction, purification, and analysis. Develop systems and protocols for robotic RNA processing.
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Research AssociateUniversity Of Texas At Austin Jun 2000 - Feb 2002Austin, Tx, UsResponsible for maintenance of lab stocks, records, ordering, etc.; training and oversight of junior staff; research into genetics and molecular pathways in model organism. • Perform molecular/genetic experiments in Dictyostelium• Contribute to grant proposals and journal articles• Manage laboratory and train and oversee staff
Michael Siano Skills
Michael Siano Education Details
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University Of California, Santa Cruz& Developmental Biology -
The University Of Texas At AustinMicrobiology
Frequently Asked Questions about Michael Siano
What company does Michael Siano work for?
Michael Siano works for Cardiosense
What is Michael Siano's role at the current company?
Michael Siano's current role is Regulatory Affairs Professional | Medical Devices & IVDs.
What is Michael Siano's email address?
Michael Siano's email address is mi****@****ail.com
What is Michael Siano's direct phone number?
Michael Siano's direct phone number is +151279*****
What schools did Michael Siano attend?
Michael Siano attended University Of California, Santa Cruz, The University Of Texas At Austin.
What skills is Michael Siano known for?
Michael Siano has skills like Biotechnology, Technical Writing, Regulatory Affairs, Medical Devices, Research, Sql, Life Sciences, Data Analysis, Regulatory Submissions, Lifesciences, Fda, Product Development.
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