• 11-Sep-2018 to 10-Nov-2018 (CST)
  • Regulatory
  • Minneapolis, MN, USA
  • Salary
  • Full Time

Medical, Dental, Group Life Insurance, Voluntary Life Insurance, Disability, 401(k) Plan, Flexible Spending Plans, Tuition Reimbursement, Paid Time Off (PTO) and Holiday Pay

Be involved with a company that is changing the lives of people across the globe.

ARKRAY is currently looking to fill a Regulatory Affairs Manager position responsible for managing programs and processes assuring regulatory compliance of ARKRAY products in a pre-market regulatory and project management role.

This position is not a supervisory role.

Duties and Responsibilities

  • Prepare and submit regulatory applications including Pre-submissions, IDE, 510(k) and CLIA Waiver.
  • Negotiate with FDA and other regulatory authorities on regulatory applications and approvals.
  • Report to management on status, plans and strategies to obtain product approvals.
  • Maintain regulatory product files to ensure compliance with regulatory requirements.
  • Direct hands-on involvement with project management activities on assigned projects for successful project execution.
  • Support domestic and international project development teams throughout the development process to ensure good regulatory submissions.
  • Interact with product launch and post-market team members to ensure a smooth transition from pre-market to post-market phase.
  • Prepare printed materials including user manuals, product inserts, product labeling and other technical documentation.

Knowledge and Skills:

  • Bachelor's Degree in Regulatory, Chemistry, Biology, or other technical field.
  • 3+ years' experience in regulatory affairs in Class II and III products, preferably with laboratory and Point of Care IVD instruments and reagents and/or blood glucose monitoring devices.
  • Experience handling medical device regulatory submissions related to infectious diseases is preferred.
  • Experience of direct relationship and involvement dealing with FDA related to submissions, preparation and follow up.
  • Proven proactive project management, team-based skills.
  • Notable technical writing skills; ability to grasp and communicate strategic issues as well as tactical ones.
  • Computer skills such as Word, Excel, PowerPoint, Project.

ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities are encouraged to apply.

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