Regulatory Manager
Current
Feb 2024 - Present
AeroLeads people directory · profile
Michael Siano Email & Phone Number
Regulatory Manager
at
Cardiosense
1 work email found
@enovis.com
3 phones found area 512 and 408
LinkedIn matched
✓ Verified Jun 2026
4 data sources
Profile completeness 100%
Who is Michael Siano? Overview
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Quick answer
Michael Siano is listed as Regulatory Manager at Cardiosense, based in Austin, Texas, United States. AeroLeads shows a work email signal at enovis.com, phone signal with area code 512, 408, and a matched LinkedIn profile for Michael Siano.
Michael Siano previously worked as Senior Program Manager, RA at Enovis and Senior Regulatory Consultant at Emergo By Ul. Michael Siano holds Ba, Molecular, Cellular, & Developmental Biology from University Of California, Santa Cruz.
Company email context
Email format at Cardiosense
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{first}.{last}@enovis.com
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AeroLeads found 1 current-domain work email signal for Michael Siano. Compare company email patterns before reaching out.
Profile bio
About Michael Siano
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.
Listed skills include Biotechnology, Technical Writing, Regulatory Affairs, Medical Devices, and 30 others.
Current workplace
Michael Siano's current company
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12 roles · 7 years
Michael Siano work experience
A career timeline built from the work history available for this profile.
Senior Program Manager, Ra
Responsible 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.
Jul 2021 - Nov 2023
Senior Regulatory Consultant
- Perform 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.
- Support and train new/junior staff
- Support internal quality system; contribute to process development and SOPs
Apr 2020 - Jul 2021
Regulatory Affairs Consultant
Provide 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.
Aug 2018 - Apr 2020
Senior Global Regulatory Specialist
- 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.
- Monitor global regulatory updates and maintain regulatory intelligence database
- Manage small team of associates
Oct 2010 - Aug 2018
Advisor, Workspaces @ Texas Health Colab
Advised early-stage medical device startup companies on regulatory strategy, product classification, and quality system development.
2019 - 2020
~1 yr
Software Developer/Technical Writer
- Responsible 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
Feb 2007 - Aug 2010
Product Owner
Sapling Systems
- Responsible for obtaining development input requirements from internal and external stakeholders, preparing specifications, prioritizing tasks for development cycle, and performing validation of new features..
- Plan and schedule software development work using Agile process
- Write and execute test cases for software validation
- Manage and maintain software documentation
Aug 2005 - Feb 2007
Freelance Writer
Various
- Work with clients to determine project requirements, timelines, and outputs.
- Author various works in science education (textbook sections, end of chapter quizzes, etc.)
Dec 2004 - Aug 2005
Scientific Editor
- Responsible 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.)
Jul 2003 - Dec 2004
Research Associate Ii
Develop kits for RNA extraction, purification, and analysis. Develop systems and protocols for robotic RNA processing.
Mar 2002 - Jun 2003
Research Associate
- Responsible 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
Jun 2000 - Feb 2002
2 education records
Michael Siano education
Ba, Molecular, Cellular, & Developmental Biology
University Of California, Santa Cruz
Ma, Microbiology
The University Of Texas At Austin
FAQ
Frequently asked questions about Michael Siano
Quick answers generated from the profile data available on this page.
What company does Michael Siano work for?
Michael Siano works for Cardiosense.
What is Michael Siano's role at Cardiosense?
Michael Siano is listed as Regulatory Manager at Cardiosense.
What is Michael Siano's email address?
AeroLeads has found 1 work email signal at @enovis.com for Michael Siano at Cardiosense.
What is Michael Siano's phone number?
AeroLeads has found 3 phone signal(s) with area code 512, 408 for Michael Siano at Cardiosense.
Where is Michael Siano based?
Michael Siano is based in Austin, Texas, United States while working with Cardiosense.
What companies has Michael Siano worked for?
Michael Siano has worked for Cardiosense, Enovis, Emergo By Ul, Dell Medical School At The University Of Texas At Austin, and Compeat Restaurant Management Systems.
How can I contact Michael Siano?
You can use AeroLeads to view verified contact signals for Michael Siano at Cardiosense, including work email, phone, and LinkedIn data when available.
What schools did Michael Siano attend?
Michael Siano holds Ba, Molecular, Cellular, & Developmental Biology from University Of California, Santa Cruz.
What skills is Michael Siano known for?
Michael Siano is listed with skills including Biotechnology, Technical Writing, Regulatory Affairs, Medical Devices, Research, Sql, Life Sciences, and Data Analysis.
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