Pro Staff

International Regulatory Affairs Associate

Employer
Pro Staff
Location
Plymouth, MN
Posted
Sep 11, 2018
Closes
Oct 11, 2018
Ref
338574
Contact
Pro Staff
Category
Other
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 International Regulatory Affairs Associate you will work with local regulatory agents and distributors to assist in preparation, compilation, and maintenance of regulatory registrations to government agencies with a particulat emphasis on China, Asia/Pacific (APAC), Middle East and Africa (MEA), and other international markets. Additionally, you will assist in the determination and definition of regulatory requirements for project teams and stakeholders throughout the organization. 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: 6-12 Month Contract - Contract to Hire for the Right Fit

Job Duties:
  • Collaborate and execute regulatory strategies for global registrations and compliance with particular emphasis on China, APAC, MEA and other international markets
  • Work with local regulatory agents and distributors to assist in the preparation, compilation and maintenance of regulatory registrations in China, APAC, MEA, and other international markets
  • Obtain CFGs and co-ordinate document legalization to support international regulatory submissions
  • Complete change control documentation for regulatory related product and label changes
  • Have a basic understanding of pertinent regulations, standards and guidance documents that dictate compliance requirements for all Cantel products
  • Participate on project teams to provide regulatory input as assigned
  • Assist in the determination and definition of regulatory requirements for project teams and stakeholders throughout the organization
  • Maintain and organize regulatory affairs files and documentation
  • Assist in implementing department procedures and provide support to RA team, and perform other related duties and assignments as required
  • Requirements:
    • BS/BA degree in an engineering or scientific discipline with 0-2 years of experience in International regulatory affairs/compliance
    • Basic knowledge of regulations pertaining to medical devices
    • Strong regulatory compliance documentation skills
    • 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
    Preferred, but Not Required:
    • Proficiency in a foreign language such and Mandarin
    • BS degree in Biology or Biomedical Engineering
    • Experience in preparing regulatory submissions and associated documents legalization
    • Experience in medical device regulatory affairs preferred

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