Andre L.

Director, Regulatory Affairs and Quality Assurance at Spaulding Medical

Andre L. has a diverse work experience in regulatory affairs and quality assurance. Andre started their career at Sigma Aldrich as a Chemical Operator, where they were responsible for various laboratory tasks. Andre then worked at Unilever as a Compliance Specialist in Quality Assurance, ensuring quality control throughout the manufacturing process. Andre then joined Life Technologies as a Regulatory Affairs Analyst, leading NPI and software development teams and managing international registrations. Andre then moved on to Spaulding Clinical Research as a Manager of Regulatory Affairs, where they oversaw the regulatory affairs department and handled global registration packages. Next, they joined Nemschoff as an FDA Compliance Manager, ensuring complaint and medical device reporting system compliance. Most recently, Andre has been working at American Orthodontics as a Regulatory Affairs Coordinator, where they manage product registration strategies, performs QMS remediation, and leads internal and external audits. Andre currently holds the position of Director, Regulatory Affairs and Quality Assurance at Spaulding Medical.

Andre L. has a Bachelor's degree from the University of Wisconsin-Milwaukee. Andre studied Biology as their major and Chemistry as their minor. In addition to their degree, Andre obtained a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society (RAPS) in July 2013.

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