Regulatory Manager - Medical

Horiba Ltd   •  

Irvine, CA

Industry: Manufacturing & Automotive

  •  

8 - 10 years

Posted 56 days ago

The HORIBA Group of worldwide companies provides an extensive array of instruments and systems for applications ranging from automotive R&D, process and environmental monitoring, in-vitro medical diagnostics, semiconductor manufacturing and metrology, to a broad range of scientific R&D and QC measurements. Proven quality and trustworthy performance have established widespread confidence in the HORIBA Brand.

Our North American Medical group is searching for an experienced regulatory professional to lead the activities for the development, coordination, and execution of the clinical trial activities and the US clinical site studies in support of 510K submissions. Please keep reading and visit our corporate website www.horiba.comOpens a New Window. to learn more.

Key Responsibilities:

  • Point person with clinical sites, reviews and prepares clinical study protocol, including data management in support of 510K submissions.
  • Facilitates search and qualification of clinical sites in the US including site start-up activities and study protocol training
  • Manages information to be submitted to regulatory authorities and acts as liaison.
  • Interprets regulations and provides sales, marketing, and global regulatory teams with constructive regulatory guidance and recommendations.
  • Support completion of product license applications, develop content/format for regulatory submissions, such as 510(k)'s and Canadian registrations for IVD products.
  • Serve as Regulatory Affairs representative in review and approval of marketing/promotional, sales training, packaging & labeling materials
  • Participates in obtaining 510(k) clearance, contributes to writing pre-submissions and 510(k) submittals, and interacts with FDA in matters related to pre-submissions, 510(k) files and follow-up meetings

Desired Qualifications:

  • M.S. with 4 to 6 years of experience; B.S. degree with 7 to 9 years of experience; and/or equivalent combination of education and experience: Clinical Chemistry, Hematology, Clinical Studies, and Statistical Data Analysis required.
  • Analytical thinking and problem solving skills
  • Excellent communication skills, verbal and written
  • Excellent interpersonal skills and leadership potential with excellent negotiation skills
  • Computer literate with in-depth knowledge of the electronic systems for electronic storage and submission
  • Expert knowledge of Medical Device regulations
  • Familiar with product registrations (globally)
  • Experience in GLP, IVD, the biomaterials and/or human tissue industry preferred.

HORIBA Instruments offers a competitive compensation package that includes a 401(k) plan with match; employee group dental, vision, life, and disability (short and long-term) paid for by the company; medical insurance, family dental and vision insurance, and supplemental life insurance available with reasonable employee contributions; employee assistance program; paid holidays, vacation, and sick time; flexible spending accounts; and educational reimbursement and commuter benefit programs.