Timothy Placek
Principal Consultant RETIRED at Placek Regulatory Consulting (PRC) | Pearland, Texas, United States
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Timothy Placek is a distinguished Principal Consultant at Placek Regulatory Consulting (PRC), where he leverages over 35 years of extensive experience in regulatory affairs and quality management within the medical device sector. His expertise encompasses a comprehensive range of services tailored to meet the diverse needs of small, medium, and large medical device manufacturers. Tim specializes in developing robust quality systems that comply with international standards, including ISO 14971, and is adept at conducting thorough internal and supplier audits to ensure adherence to regulatory requirements.
At PRC, Tim has spearheaded numerous key projects that focus on regulatory submissions and compliance strategies for Class II and Class III medical devices. His hands-on approach to technical writing and SOP development has empowered clients to navigate complex regulatory landscapes effectively. Tim's proficiency in risk management, CAPA (Corrective and Preventive Actions), and design control management has proven invaluable in helping organizations remediate technical files and enhance their quality planning processes.
Tim's commitment to fostering a culture of quality assurance is evident in his training programs, which equip teams with the knowledge and skills necessary to maintain compliance and drive continuous improvement. His experience in negotiating product approvals and clearances with the FDA and international regulatory bodies has made him a trusted advisor in the industry. As a retired professional, Tim continues to share his wealth of knowledge, ensuring that the next generation of regulatory and quality professionals is well-prepared to meet the challenges of an ever-evolving landscape in the life sciences sector.
Principal Consultant RETIRED at Placek Regulatory Consulting (PRC) in March 2012 to Present
Founder and Principal at Placek & Associates, LLC in January 2012 to August 2022
VP of Regulatory Affairs at Spinal Modulation in September 2009 to March 2012
VP Regulatory Affairs, Clinical Affairs, Quality Systems at IDEV Technologies, Inc. in January 2006 to January 2009
President & CEO, Founder at DataMatrix, Inc. in January 2005 to January 2008
SVP, Regulatory Affairs, Clinical Affairs, Quality at MicroMed Cardiovascular, Inc. in January 1998 to January 2008
VP of Regulatory Affairs and Quality Systems at Cardiologic Systems, Inc. in January 1996 to January 1998
Quality Assurance Manager at Orthofix, Inc. in January 1994 to January 1996
VP of Regulatory Affairs and Quality Assurance at Everest & Jennings, Intl. in January 1992 to January 1994
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Medical Devices
Design Control
FDA
Quality System
Clinical Trials
ISO 13485
Clinical Research
GCP
Product Launch
Strategy
ISO 14971
Manufacturing
Biomedical Engineering
V&V
Lifesciences
PMA
Commercialization
Hardware Diagnostics
CE marking
Validation
CRO
R&D
Regulatory Affairs
CAPA
Regulatory Submissions
GMP
21 CFR
Quality Assurance
Biotechnology
Clinical Development
Biocompatibility
Pharmaceutical Industry
Capital Equipment
Life Sciences
Verification and Validation (V&V)
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What is Timothy Placek email address?
Email Timothy Placek at [email protected]. This email is the most updated Timothy Placek email found in 2026.
What is Timothy Placek phone number?
Timothy Placek phone number is +18327665822 and +17134447707.
How to contact Timothy Placek?
To contact Timothy Placek send an email to [email protected]. If you want to call Timothy Placek try calling on +18327665822 and +17134447707. (updated on October 29, 2024)
What is Timothy Placek net worth?
Timothy Placek has an estimated net worth of $375,000 to $499,999
What company does Timothy Placek work for?
Timothy Placek works for Placek Regulatory Consulting (PRC)
What is Timothy Placek's role at Placek Regulatory Consulting (PRC)?
Timothy Placek is Principal Consultant RETIRED
What industry does Timothy Placek work in?
Timothy Placek works in the Medical Equipment Manufacturing industry.
Timothy Placek Email Addresses
Timothy Placek Phone Numbers
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