Adam Simon
Senior Regulatory Affairs Specialist at Johnson & Johnson MedTech | Spring Hope, North Carolina, United States
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Adam Simon is a seasoned Senior Regulatory Affairs Specialist at Johnson & Johnson MedTech, where he leverages his extensive experience in the medical device industry to navigate the complex regulatory landscape. With a robust background in regulatory documentation and compliance, Adam excels in developing strategic submission plans for innovative medical devices, ensuring they meet the stringent requirements set forth by the U.S. Food and Drug Administration (FDA) and the European Union (EU). His expertise encompasses a wide range of regulatory frameworks, including the implementation of the EU Medical Device Regulation (MDR) and the management of Unique Device Identification (UDI) requirements, which are critical for maintaining product traceability and safety.
In his current role, Adam is instrumental in assessing the regulatory impact of design changes across Class II, IIb, and III devices, providing valuable insights that guide product development and risk management strategies. His proficiency in Corrective and Preventive Action (CAPA) processes further enhances his ability to ensure compliance while fostering a culture of continuous improvement within the organization. As a Regulatory Affairs Project Manager, Adam leads cross-functional teams, coordinating efforts to streamline regulatory submissions and mitigate potential roadblocks.
Adam's strong analytical skills, coupled with his adeptness in trend analysis and quality auditing, enable him to identify emerging regulatory trends and adapt strategies accordingly. His commitment to training and mentoring colleagues in regulatory affairs not only strengthens team capabilities but also reinforces Johnson & Johnson MedTech's dedication to excellence in product safety and efficacy. With a Bachelor’s Degree in Project Management from Liberty University, Adam combines his legal acumen with practical project management skills, making him a vital asset in the ever-evolving landscape of medical device regulation.
Senior Regulatory Affairs Specialist at Johnson & Johnson MedTech in October 2022 to Present
Principal Consultant at Simon Consulting Services Inc in June 2023 to Present
Senior Regulatory Affairs Specialist at Asensus Surgical in June 2021 to October 2022
Regulatory Affairs Manager at ActiGraph in July 2015 to June 2021
Quality Assurance Manager at ActiGraph in June 2011 to July 2015
Engineering Technician at ActiGraph in September 2010 to June 2011
Avionics Technician and Work Center Supervisor at United States Marine Corps in July 2005 to July 2010
Owner and Operator at Buzz Cuts in January 1997 to July 2005
Parts Runner at Southwest Town Mechanical in May 2003 to August 2003
Assistant at Roeda Signs Inc. & ScreenTech Imaging in May 2002 to August 2002
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Quality Auditing
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CAPA
Microsoft Office
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Customer Service
Testing
ISO 13485
Negotiation
Management
Public Speaking
Time Management
FDA
Document Management
Project Management
Trend Analysis
Performance Reporting
Internal Audit
Employee Training
Basecamp
Google Docs
FogBugz
Regulatory Submissions
Regulatory Documentation
Operational Risk Management
Code of Federal Regulations
FCC
ANVISA
IEC 60601
21 CFR 820
Regulatory Affairs
Regulatory Compliance
Circuit Testing
Fiber Optics
Multimeter
Conflict Resolution
Conflict Management
FDA GMP
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Google Drive
Military Aviation
Military Experience
Military Training
Marine Corps
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Supply Chain Management
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Discover more about Johnson & Johnson MedTechWhat is Adam Simon email address?
Email Adam Simon at [email protected] and [email protected]. This email is the most updated Adam Simon email found in 2026.
What is Adam Simon phone number?
Adam Simon phone number is +18503160331 and +17084209097.
How to contact Adam Simon?
To contact Adam Simon send an email to [email protected] or [email protected]. If you want to call Adam Simon try calling on +18503160331 and +17084209097. (updated on September 13, 2024)
What is Adam Simon net worth?
Adam Simon has an estimated net worth of $2,500 to $24,999
What company does Adam Simon work for?
Adam Simon works for Johnson & Johnson MedTech
What is Adam Simon's role at Johnson & Johnson MedTech?
Adam Simon is Senior Regulatory Affairs Specialist
Adam Simon Email Addresses
Adam Simon Phone Numbers
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