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Regulatory Affairs Manager

Company: LHH
Location: Cuyahoga Falls
Posted on: June 16, 2022

Job Description:

LHH is seeking a full-time Regulatory Affairs Manager to join our close-knit growing team. If you are interested in developing regulatory staff and driving corporate policies, please keep reading.Responsibilities:

  • Oversee regulatory systems and processes and maintain compliance with domestic and international regulatory standards for medical device registrations, pesticide registrations, drug registrations, electrical safety registrations through verification, auditing, and validation
  • Develop and guide processes, product compliance strategies, programs, policies, and systems
  • Manage submissions, direct assessments, issues, and risks for company products
  • Prepare, monitor, and maintain operating budgets
  • Communicate cross-functional personnel to multiple departments to achieve desired objectives
  • Maintain organizational policies, procedures, and focus on continuous improvements
  • Manage 4-5 regulatory affairs specialist direct reports, responsible for performance and hiring of employeesQualifications:
    • 3 to 5 years of progressive experience in regulatory affairs required
    • 1 to 2 years of leadership or supervisory experience
    • Bachelor's degree in science, mathematics, engineering, or other technology fields
    • Management, supervisor, or leadership experience
    • In-depth knowledge of 21CFR 820, ISO13485, MDD/MDR, and QMS requirements
    • Medical device products experience preferred
    • ASQ, Six Sigma, RAPS, or other regulatory certifications
    • Technical capacity, proficient in Microsoft Office Suite (Word, Excel, Project, Visio, PowerPoint, Outlook)Expectations:
      • Hours are Monday- Friday (8:00 am- 5:00 pm) 3 days WFH, 2 days onsite
      • Full benefits, including pet insurance, and other perks
      • Generous PTO, vacation, and sick days
      • Diverse and growth-minded company

Keywords: LHH, Cuyahoga Falls , Regulatory Affairs Manager, Executive , Cuyahoga Falls, Ohio

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