Regulatory Manager - Medical

The HORIBA Medical Segment designs, develops and distributes worldwide, in vitro diagnostic systems mainly destined for biological analysis in medical laboratories. These automated analyzers meet the needs of various users including patients, doctors, private laboratories, clinics and university hospitals. HORIBA expertise in in vitro diagnostics is one of the most respected in hematology worldwide and contribute today to the health of tomorrow.

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.

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.

If you are an individual with a disability and need an accommodation during the application/hiring process, please contact HORIBA for assistance. HORIBA will provide reasonable accommodations, upon request, to support individuals with disabilities to be able to participate in the hiring process. HORIBA is committed to making our workplace accessible for individuals with disabilities.

EEO/Affirmative Action/Veteran Status/Disabilities

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