Heather Neely

RAC, CQA

Principal Regulatory Consultant

As a seasoned expert with more than 20 years of experience in the pharmaceutical, biotech and medical device industry, Heather brings a world of knowledge to MRC Global. As Principal Regulatory Consultant at MRC, she leverages her vast knowledge, influence and leadership abilities to effectively facilitate collaboration and consensus among cross functional teams.

Heather’s expertise includes regulatory submissions, audits, project management, microbiology and equipment validation. Consistently applying proactive problem-solving skills to every situation, she’s demonstrated tremendous flexibility and adaptability throughout her career. As a very organized, dedicated and detailed professional, Heather brings a new level of efficiency to every project, elevating performance and quality while accelerating timelines.

Having been the director of regulatory affairs/quality assurance (RA/QA) for leading pharmaceutical, biotech and medical device companies in California and Colorado, and having worked on leading drug/device brands, Heather’s ability to navigate this complex arena is exceptional. As a thought-leader and sought-after expert, Heather is well versed in processes/protocols including FDA, MDR, MDD, CFDA, PMDA, SOPs, USP, cGMP, GLP, GCP and ISO.

Heather has Regulatory Affairs Certification (RAC) and is an ASQ Certified Quality Auditor (CQA) from Northeastern University, Boston and holds a bachelor’s degree in environmental, population and organismic biology with a minor in biochemistry from the University of Colorado, Boulder.

Highlights
  • More than 20 years of pharmaceutical, biotech, and medical device industry experience
  • Expert in regulatory submissions, audits, project management, microbiology, and equipment validation
  • Regulatory Affairs Certification (RAC)
  • ASQ Certified Quality Auditor (CQA)