Regulatory And Quality Professional@ Lexington Medical, Inc
Broomfield, Colorado, United States
Olga Lewis
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San Diego State University
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FlashIntel GPTOlga Lewis is a highly experienced Lead Regulatory Affairs Specialist with 17.4 years of work experience in the medical devices and pharmaceutical industry. She has a strong background in regulatory affairs, FDA regulations, and quality systems. Olga has held various leadership positions in reputable companies such as Lexington Medical, Inc, Neocis, Medtronic, and NuVasive. She is currently working at NuVasive as the Lead Regulatory Affairs Specialist. Olga's expertise lies in regulatory submissions, quality assurance, and product launch. She is based in Broomfield, Colorado.
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About
Lead Regulatory Affairs Specialist at NuVasive
Work Experience
Regulatory And Quality Professional
Head Of Quality Assurance | Research And Development
Medical Equipment Manufacturing
Olga Lewis's Professional Milestones
- Regulatory Affairs Specialist (2008-10-01~2010-04-01): Successfully streamlined regulatory processes, resulting in increased compliance and improved compliance across the organization.
- Senior Regulatory Affairs Specialist (2010-04-01~2012-03-01): Successfully navigated complex regulatory landscape, ensuring compliance and minimizing risk.
Education
Master Of Science,
Masters
2007-2013Skill
Regulatory Affairs
Medical Devices
Fda
Iso 13485
Design Control
Quality System
Capa
Validation
Biotechnology
Gmp
Regulatory Submissions
Quality Assurance
Product Launch
V&v
Iso
Life Sciences
Orthopedics
Pharmaceutical Industry
Iso 14971
Clinical Research
Biomedical Engineering
Clinical Trials
Quality Auditing
Infectious Diseases
R&d
Hardware Diagnostics
Spine
Fda Gmp
Capital Equipment
Sop
Pma
Orthopedic
Commercialization
Change Control
21 Cfr Part 11
Ce Marking
Quality Systems
Glp
Complaint Management
Clinical Development
Lifesciences
Technology Transfer
Biologics
Gcp
21 Cfr
Cardiology
Biopharmaceuticals
Cqa
510 K
Clinical
Certification
Colleagues
Li Jin
supply chain director at 3rd stone design inc
Marc Jin
Chief Operative Officer
Costas Manganiotis
vice president gm international
Shawn Riley
Vice President Sales
Rolf Wildermuth
vice president europe lexington medical chairman of the board at lexington medical schweiz ag chairman of the board at bottneuro ag
Other Named Olga Lewis
Frequently asked questions
We found 3 Olga Lewis's email addresses
We found 2 Olga Lewis's phone numbers
Olga Lewis's social media include: Linkedin,
Olga Lewis works for Lexington Medical, Inc
Olga Lewis's role in Lexington Medical, Inc is Regulatory And Quality Professional
Olga Lewis works in the industry of Medical Equipment Manufacturing
Olga Lewis's colleagues are Li Jin,Marc Jin,Costas Manganiotis
Olga Lewis's latest job experience is Regulatory And Quality Professional at Lexington Medical, Inc
Olga Lewis's latest education in San Diego State University
