Pro Staff

Regulatory Operations Associate

Employer
Pro Staff
Location
Plymouth, MN
Posted
Nov 10, 2018
Closes
Dec 10, 2018
Ref
346612
Contact
Pro Staff
Category
Other
Job Type
Employee
Employment Status
Full Time
Cantel Medical has partnered with Pro Staff to add a Regulatory Operations Associate to their team! In this role you will support and improve the Cantel Medical regulatory compliance position by completing downstream regulatory compliance tasks to help achieve RA departmental objectives. 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:  Temp to Hire -
Contract to Hire for the Right Candidate

Job Duties:

  • Completion of downstream regulatory compliance tasks to help achieve RA departmental objectives.
  • Successfully assist and execute regulatory vigilance reporting, medical device reporting, complaint handling, sustaining engineering and product recall activities.
  • Conduct complaint investigations with customers, field assurance team members for regulatory related documentation on product vigilance reports and complaints.
  • Complete domestic and international downstream regulatory affairs and post-market activities for company product lines. Update and maintain essential requirements checklists and technical files for products sold in the EU market.
  • Maintain and verify sales order control data of Cantel regulated products.
  • Review and determine regulatory implications and requirements of product, labeling and/or other change control documentation or design changes.
  • Participate on project teams to provide regulatory input as assigned. Prepare post-market regulatory strategies, plans, documentation and submissions for the products assigned.
  • Provide support for regulatory compliance inspections/audits of Cantel Medical facilities.
  • Support continuous improvement initiatives for downstream regulatory compliance processes.
  • Assist in the development and maintenance of Safety Data Sheets and labeling required for Cantel Medical products in accordance with the latest regulations.
  • Prepare and assist with EPA related submissions and registrations.
  • Provide Regulatory support in the pre and post entry review of import and export compliance.
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 and effective time-management skills.
  • Experience in U.S. and international regulatory complaint handling and reporting is preferred.
  • General computer knowledge and working ability with MS office programs is required.

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