Greenleaf Health announces that Kristen Grumet has joined the firm as Senior Vice President, Regulatory Compliance.  The addition of Grumet to Greenleaf’s team of experts further enhances the firm’s expanded portfolio of comprehensive compliance services, which now include inspection readiness, on-site compliance assessments, and remediation.

About Grumet

Kristen Grumet is an expert in the field of medical device compliance.  In addition to almost a decade of experience as an FDA field investigator, Grumet’s professional background includes 16-years of quality systems compliance management and consulting within the medical device industry.

A Phase II-certified medical device performance auditor, Kristen has the distinction of being among the first cadre of certified medical device investigators in FDA history. During her service at the FDA, Grumet inspected both domestic and International medical device manufacturers to ensure compliance with Quality System Regulations (QSRs).  Grumet was responsible for documenting and developing numerous regulatory cases, including warning letters, seizures and corporate-wide injunctions.

Grumet’s 20+ years of industry experience includes positions at NSF Health Sciences; Intuitive Surgical, Inc.; Quintiles Consulting; and LifeScan, Inc.  Her work with medical device companies provided experience leading projects across the spectrum of quality assurance and regulatory compliance activities, including compliance assessments; internal audits and investigations; quality systems development and implementation; corrective action planning and quality system remediation; and QSR and FDA inspection readiness training.  Grumet’s impressive portfolio also includes numerous FDA and industry presentations and publications.

At Greenleaf, Grumet joins the firm’s Product Quality, Manufacturing & Compliance team, where she will serve as Senior Vice President, Regulatory Compliance.  In this role, Grumet will continue to provide medical technology clients with customized guidance and support in developing and implementing strong corporate quality systems and regulatory strategies for compliance.

Greenleaf’s Expanded Compliance Services

Greenleaf’s Product Quality, Manufacturing, and Compliance Team has a proven track record of providing excellent services to life science companies seeking strategic and technical expertise to strengthen their quality management systems and guide them through challenging quality and compliance matters.  In addition to Greenleaf’s core regulatory consulting services, the firm recently expanded its compliance service portfolio to include expanded remediation, auditing, and compliance services.  Greenleaf’s compliance capabilities now include:

  • Inspection Readiness:  Greenleaf experts strengthen clients’ readiness for FDA pre-approval and surveillance inspections through training, mentoring, audits and mock inspections.
  • Compliance Assessments: Greenleaf works with life science firms to evaluate and strengthen compliance functions with an eye towards optimizing processes, mitigating risks, and creating a culture of compliance.  The Greenleaf team performs objective audits and assessments of a clients’ operations to identify strengths and areas of needed improvement, while continuing to meet business objectives.
  • Compliance Remediation:  Greenleaf’s experts bring an unmatched level of experience and insight when guiding companies along the remediation pathway.Greenleaf’s services address the complete scope of remediation, from acute enforcement actions, to strategic development and implementation of remediation plans.

By expanding Greenleaf’s compliance service portfolio, the firm is now capable of providing a full-service experience for companies navigating today’s evolving FDA regulatory environment.

About Greenleaf Health

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies developing and manufacturing innovative solutions to pressing global public health challenges.

Greenleaf’s team of experts draws on a combined total of more than 200 years of FDA experience. Members of the firm’s Product Quality, Manufacturing, and Compliance Team include former leaders and regulatory experts from the FDA, Capitol Hill, top global pharmaceutical companies, leading law firms and the top U.S. biotechnology trade organization. Greenleaf’s robust blend of regulatory expertise and FDA institutional knowledge allows the firm to provide unmatched regulatory guidance.

For more information on Kristen Grumet visit her bio.