• 10-Aug-2018 to 09-Oct-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 Project Manager position responsible for managing programs and processes assuring regulatory compliance of ARKRAY products in a pre-market regulatory and project management role. Provide guidance and interpretation of regulatory requirements and regulations assuring that design and development requirements are met. Recommend and implement compliance strategies for existing, new and proposed products or product changes.

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.
  • 5-7 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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