Senior Corporate Counsel About the Company Well-known provider of clinical laboratory services
Industry
Hospital & Health Care
Type
Public Company
Founded
1967
Employees
10,001+
Categories Health CareHealth DiagnosticsInformation ServicesHealth & WellnessConsulting & Professional ServicesDiagnosticDiagnostic LaboratoriesElectronic Medical RecordsHealthHealthcareHeart DiseaseHospitals Specialties Diagnostic testing information and servicesClinical testingcancer diagnostics and anatomic pathology servicesGene-based and other esoteric testingHealthcare information technology solutions Business Classifications B2BSAAS About the Role The Company is seeking a Senior Corporate Counsel with a focus on FDA Medical Device. The successful candidate will be a key legal and regulatory advisor, providing guidance on a wide range of issues related to assay discovery, development, and commercialization. This role involves serving as a proactive and ethical counselor, developing regulatory strategies, and evaluating legal and regulatory exposures. The Senior Corporate Counsel will also be responsible for ensuring compliance with company policies and legal requirements, as well as managing relationships with both internal and external clients.
Applicants must have a Doctor of Jurisprudence (J.D.) or equivalent degree, be admitted to at least one state bar, and have a minimum of 8 years' legal experience, including in the medical device, pharmaceutical, biotech, or regulatory agency settings. A strong understanding of the industry and a proven track record of partnering on clinical and marketing applications for medical products is essential. The role requires current knowledge of the Food, Drug & Cosmetic Act, FDA guidance, and international regulatory standards. Experience with EU clinical trial regulations and MDR/IVDRs is highly desirable. The ideal candidate will have strong legal drafting skills, interpersonal abilities, good judgment, and the resilience to support a growing clinical business.
Hiring Manager Title
Chief FDA Counsel
Travel Percent
Less than 10%
Functions Legal
