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