Pro Staff

Post-market Regulatory Affairs Associate

Employer
Pro Staff
Location
Plymouth, MN
Posted
Feb 28, 2018
Closes
Mar 22, 2018
Ref
317540_1
Contact
Pro Staff
Category
Marketing
Job Type
Employee
Employment Status
Full Time
Pro Staff has teamed with Medivators and Cantel to add a Post-Market Regulatory Affairs Associate to their team! Cantel Medical is a leader in medical devices, specializing in Endoscopy. As the Post-Market RA Associate you will assist in the execution of regulatory vigilance reporting, medical device reporting, complaint handling, sustaining engineering, field assurance, and product recall activities. Additionally, you will assist in completion or domestic and international downstream regulatory affairs and post-market activities for company product lines. You will also be responsible for facilitating the achievement of business objective and support maintenance of compliant operations through completion of compliance task as directed. If you are looking to join a fast 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 Fit

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
  • 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
  • Support continuous improvement initiatives for downstream regulatory compliance processes
  • Assist in the development and maintenance of Safety Data Sheets required for Cantel Medical products in accordance with the latest regulations
  • Provide Regulatory support in the pre and post entry review of import and export compliance
Requirements:
  • BS degree in scientific, engineering or technical discipline
  • 0-2 years of experience in regulatory affairs, preferably in medical devices, or equivalent
  • Masters degree preferred
  • 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
  • Demonstrate independent problem solving skills and solid written/verbal communication skills
  • Strong attention to detail
  • 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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