Cecil Gaff

I have over 20 years of experience in regulatory affairs and quality assurance, particularly in the medical device and healthcare industries. I’ve led teams in developing and implementing robust Quality Management Systems, ensuring compliance with FDA cGMP, ISO 13485, and global regulatory frameworks (Domestic and International) like EU MDR and CMDCAS, with extensive formulary, product, and process validation, product and audits

Throughout my career, I’ve successfully managed 510(k) submissions and other global regulatory filings, working closely with R&D, manufacturing, and commercial teams to streamline processes while maintaining compliance.

PROFILE SUMMARY__________________________________________________________________________________

Dynamic regulatory and quality assurance leader with over 20 years of experience in the medical device, pharmaceutical, and food industries. Proven track record in regulatory submissions, quality management systems (QMS), and continuous improvement initiatives. Skilled at leading cross-functional teams to enhance productivity, safety, and quality. Exceptional communicator with strong project management and technical documentation skills, driven by a commitment to excellence and innovation.

CERTIFICATIONS__________________________________________________________________________________________

• Certified Lean Six Sigma Green Belt: Expertise using the DMAIC model to enhance problem-solving abilities and propel process improvement. Proven ability to drive measurable outcomes through Lean Manufacturing principles.
• ISO 9001/13485 Lead Auditor: Certified Lead Auditor with expertise in conducting internal and external audits of Quality Management Systems (QMS) in compliance with regulatory standards.
• Certified Lead Auditor – ISO 13485: Expertise in conducting internal and external audits in compliance with ISO 13485 and global regulatory standards.

EDUCATION_______________________________________________________________________________________________

Bachelor of Science/Troy University - Troy, AL – 1989