beBee background
Professionals
>
Northport
Cecil Gaff

Cecil Gaff

Director of Quality and Regulatory Affairs

Healthcare

Northport, Tuscaloosa

Social

1 Followers

Services offered

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. 

Regulatory affairs
Quality assurance
Medical device
Approximate rate: USD$ 100 per hour

Experience

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.

Education

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

Professionals in the same Healthcare sector as Cecil Gaff

Professionals from different sectors near Northport, Tuscaloosa

Other users who are called Cecil

Jobs near Northport, Tuscaloosa

  • Work in company

    External Affairs Operations Coordinator

    University of Alabama

    The External Affairs Operations Coordinator will report to the Director of External Affairs and support the Office of External Affairs by assisting with UA System legislative priorities projects daily operations. · ...

    Tuscaloosa, AL

    1 month ago

  • The Assistant Director Student Leadership Programming creates comprehensive opportunities for leadership development and campus engagement for the entire campus population in assigned department. · ...

    Tuscaloosa, AL

    1 month ago

  • Work in company

    Associate Chief of Staff Geriatrics

    U.S. Department of Veterans Affairs

    The Associate Chief of Staff (ACOS) for Geriatrics and Extended Care (GEC) Service Line is responsible for the overall leadership of the service line and ensures the quality of medical and mental health services provided - the education and training of professional staff - and th ...

    Tuscaloosa

    1 month ago