Regulatory Affairs Consultant - Medical Devices
Self-Employed
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Alex Friedman Email & Phone Number
Regulatory Affairs Consultant - Medical Devices
at
Self-employed
1 work email found
@beckmancoulter.com
1 phone found area 800
LinkedIn matched
✓ Verified Jul 2026
4 data sources
Profile completeness 100%
Current company
Role
Regulatory Affairs Consultant - Medical Devices
Location
Pittsburgh, Pennsylvania, United States
Who is Alex Friedman? Overview
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Quick answer
Alex Friedman is listed as Regulatory Affairs Consultant - Medical Devices at Self-employed, based in Pittsburgh, Pennsylvania, United States. AeroLeads shows a work email signal at beckmancoulter.com, phone signal with area code 800, and a matched LinkedIn profile for Alex Friedman.
Alex Friedman previously worked as Staff Regulatory Specialist at Beckman Coulter Diagnostics and Senior Regulatory Affairs Engineer at Philips Respironics. Alex Friedman holds Ph.D., Bioengineering from University Of Pennsylvania.
Company email context
Email format at Self-employed
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{first_initial}{last}@beckmancoulter.com
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Profile bio
About Alex Friedman
Strategies for innovative AI-enabled SaMD and electromechanical devices, from concept to market.Authentic regulatory professional who gains the trust and respect of teammates and multi-disciplinary leaders to achieve solid SaMD/AI and electromechanical regulatory strategies and submissions. Experienced in submissions of low to moderate-high risk devices and recognized as an expert in AI-enabled and clinical decision support software. Working knowledge of regulatory requirements for basic safety and essential performance, usability, biocompatibility and reprocessing of medical devices. Passionate about leveraging self- and team-expertise to guide new products through regulatory processes, and proactively share best practices, creative strategies and regulatory knowledge. Balances regulatory and business risks to accelerate best in class solutions to market, and total product life cycle solutions.* Global submissions preparation and additional information responses* AAMI TIR34971, IEC 62304, IEC 60601, IEC 62366, ISO 10993, TIR12* Strategies development and alignment* Business partner regulatory due diligence * Guidance documents interpretation* Regulatory intelligence and research* Design History File review and critical feedback* White papers, dynamic presentations and training* Teaming to find solutions* Technical file maintenance
Listed skills include Medical Devices, Biotechnology, R&D, Product Development, and 12 others.
Current workplace
Alex Friedman's current company
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10 roles · 20 years
Alex Friedman work experience
A career timeline built from the work history available for this profile.
Staff Regulatory Specialist
Current
Aug 2022 - Present
Senior Regulatory Affairs Engineer
Mar 2013 - Aug 2022
Regulatory Engineer
Aug 2010 - Mar 2013
Senior Regulatory And Quality Engineer
Regulatory And Quality Solutions, Llc
Jul 2009 - Aug 2010
Quality Assurance Manager
I designed, implemented and managed quality assurance and quality control systems.
Sep 2007 - Jun 2009
Consultant
Franklin Scientific Consulting
I managed high tech, biotech and bioengineering projects for organizations on an as-needed basis. The projects have included technology evaluations for business potential, quality management, clinical trial management, program design and launch, organizational communication systems, grant writing and others. As a consultant I also worked with non-profit and university entities to help commercialize technologies.
Jan 2005 - Sep 2007
Consultant / Project Manager
Renal Solutions
I organized the interactions between the clinical training staff, logistics, service and regulatory compliance. Communication was improved, problems solved more quickly and team morale raised.
2007 - 2007
R&D Scientist / Product Sustaining Manager
As a scientist I evaluated new technologies to improve the performance of high content screening instrumentation. I also managed a number of small, and one large, product development projects. I am lead author on the third Cellomics patent, and co-author on two other patents. I also developed manufacturing and service trade secrets. As Product Sustaining Manager I tracked and reported on the company's response to Customer Complaints and Product Defects. I also drove the delivery of the solutions to the customers by setting up a tracking system in Customer Relationship Management database, and interacting with the various personnel to identify problems and solve them.
May 1998 - Aug 2004
Postdoctoral Fellow
As a postdoc I performed research on novel myosin ATPases (proteins). More specifically I expressed and purified mutant myosin molecules that hydrolyzed ATP very slowly. These constructs allowed for one of the first measurements of the ATP off-rate from a myosin molecule because ATP is hydrolized quickly in wild-type myosin. The work was part of an international collaboration.
Mar 1995 - Apr 1998
2 education records
Alex Friedman education
Ph.D., Bioengineering
University Of Pennsylvania
B.S., Applied Physics
Binghamton University
FAQ
Frequently asked questions about Alex Friedman
Quick answers generated from the profile data available on this page.
What company does Alex Friedman work for?
Alex Friedman works for Self-employed.
What is Alex Friedman's role at Self-employed?
Alex Friedman is listed as Regulatory Affairs Consultant - Medical Devices at Self-employed.
What is Alex Friedman's email address?
AeroLeads has found 1 work email signal at @beckmancoulter.com for Alex Friedman at Self-employed.
What is Alex Friedman's phone number?
AeroLeads has found 1 phone signal(s) with area code 800 for Alex Friedman at Self-employed.
Where is Alex Friedman based?
Alex Friedman is based in Pittsburgh, Pennsylvania, United States while working with Self-employed.
What companies has Alex Friedman worked for?
Alex Friedman has worked for Self-Employed, Beckman Coulter Diagnostics, Philips Respironics, Regulatory And Quality Solutions, Llc, and Cellumen, Inc..
How can I contact Alex Friedman?
You can use AeroLeads to view verified contact signals for Alex Friedman at Self-employed, including work email, phone, and LinkedIn data when available.
What schools did Alex Friedman attend?
Alex Friedman holds Ph.D., Bioengineering from University Of Pennsylvania.
What skills is Alex Friedman known for?
Alex Friedman is listed with skills including Medical Devices, Biotechnology, R&D, Product Development, Quality Assurance, Regulatory Affairs, Iso 13485, and Fda.
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