Pro Staff

Regulatory Affairs Project Coordinator

Employer
Pro Staff
Location
Plymouth, MN
Posted
Mar 01, 2018
Closes
Mar 22, 2018
Ref
317569_1
Contact
Pro Staff
Category
Management
Job Type
Employee
Employment Status
Full Time
Cantel Medical has partnered with Pro Staff to add a Regulatory Affairs Project Coordinator to their team! In this role you will use project management methodologies to support the Regulatory Affairs Projects Specialist and assist in the execution of Regulatory Affairs project task and deliverables. You will also, execute Regulatory Affairs tasks and processes to support business objectives with emphasis on post-market, labeling, and sustaining engineering projects. Additionally, you will provide support for regulatory compliance inspections and audits of Cantel Medical facilities and associated follow up. If you are looking to join a growing, innovative, and collaborative team, this could be the position for you!

Pay Rate: Depending on Experience

Hours: Regular Business Hours

Duration: 
12 Month Contract - Contract to Hire for the Right Candidate

Job Duties:

  • Completion of regulatory compliance project tasks to help achieve RA departmental objectives
  • Successfully assist in continuous improvement of RA processes to support business objectives with emphasis on post-market, labeling and sustaining engineering projects
  • Utilizes project management methodologies to support the RA Project Specialist and assist in the execution of RA project tasks and deliverables
  • Support, collaborate and efficiently execute tasks assigned for projects/programs and strategies to ensure compliance to regulatory requirements
  • Determine, define and communicate regulatory requirements to cross-functional teams throughout the company with emphasis on post-market, labeling and sustaining engineering projects
  • Provide support for regulatory compliance inspections/audits of Cantel Medical facilities and associated inspection/audit follow-up
  • Assist RA Project Specialist in the management and positive relationship with external consultants and stake holders as necessary
  • Assist in the maintenance of RA departmental training program and records
  • Assist departmental management in the completion of domestic and international downstream regulatory affairs and post-market activities for company product lines
  • Assist in the maintenance of medical device excise tax, tariff coding and trade compliance item master data and documentation
  • Support execution of basic trade compliance activities such as tariff coding and trade agreement certifications
Requirements:
  • BS degree in scientific, engineering or technical discipline with 0-2 years of experience in regulatory affairs, preferably in medical devices, or equivalent
  • Basic knowledge of U.S. regulations in the areas of the FDA and international regulations such as ISO 13485 and post-market surveillance and medical device vigilance is preferred
  • Demonstrate independent problem solving skills and solid written/verbal communication skills. Strong attention to detail
  • Experience in project management preferred. Ability to handle multiple tasks and to prioritize and schedule work to meet business needs
  • General computer knowledge and working ability with MS office programs is required

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