Regulatory Manager - Hilo

Company: On Time Talent Solutions
Location: Hilo
Posted on: May 6, 2022

Job Description:

Regulatory ManagerHilo, HawaiiAlso known as "The Big Island", Hilo is the largest island in the Hawaiian Islands and is home to rainforests, volcanoes and breathtaking state parks. Also, home to Hilo Medical Center and a variety of other nationally ranked healthcare clinics, the City of Hilo has different roles that can fit what you're looking for in your next role.On Time Talent Solutions is seeking a Regulatory Manager who will work closely within the regulatory function and with all other company functions in support of product development, with the goal of delivering regulatory milestones for the company's programs. The RA manager will drive the development and implementation of regulatory strategies and operations ensuring timely delivery of regulatory submissions.Regulatory Manager Responsibilities:

• Apply a broad and advanced knowledge of regulatory standards, guidance documents, and industry expectations to product regulatory strategies and submissions
• Develop and assess policies, procedures and systems which support the submission of pricing information to federal and state agencies
• Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes
• Support Regulatory submissions / renewal and on-going regulatory compliance for product development process
• Update Risk Management files and provide input in design verification, design validation, shelf life studies
• Contribute to initiatives to improve processes within the Regulatory departmentRegulatory Manager Qualifications:
  • BA/BS degree in Life Sciences
  • RAC certification or an Advanced Degree (Masters in Regulatory Affairs) preferred
  • 5+ years of experience in an FDA regulated industry
  • Ability to lead internal and external inspection and prepare and submit the audit response to Inspectors
  • Must have knowledge and experience regarding US FDA, EMA and Safety and Quality Regulations for pharmaceuticals, medical devices and consumer health products
  • Experience in consulting for Pharmaceutical, Biotech and/or Medical Device industries strongly preferred
  • Knowledge of regulatory and compliance aspects of business processes across Life Science, to define and implement strategy, design / re-design process and support technology
  • Proficient in timely review of technical and clinical data

Keywords: On Time Talent Solutions, Hilo , Regulatory Manager - Hilo, Executive , Hilo, Hawaii