• 29-Jan-2018 to 30-May-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 and Quality Systems Project Manager position responsible for managing programs and processes assuring regulatory compliance of ARKRAY products in either a 510(k) or post market surveillance 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.

Develop, establish, and maintain Quality System processes, procedures and records ensuring compliance with the ISO 13485 standard and FDA Quality System Regulation.

Duties and Responsibilities

  • Oversee post market surveillance of currently marketed products through regulatory review and approval of product/process changes, nonconforming product, customer complaints and MDRs.
  • Establish and update Quality System processes and procedures in compliance with required ISO standards, FDA regulations and applicable guidance documents. Provide Quality Assurance oversight.
  • Review promotional material, product changes and documentation changes through Label Change Requests (LCR) to ensure compliance to FDA and Canadian regulations.
  • Participate in product launch and post market team activities.
  • Support various Quality System functions as needed including risk management, design and development, validation activities, CAPA, ISO/FDA inspections, internal/supplier audits, and QS database creation and management.
  • Maintain regulatory product files to ensure compliance with regulatory requirements.
  • Update FDA Device Listing and Establishment Registration to ensure annual compliance.
  • Prepare and submit regulatory applications including 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.

Knowledge and Skills:

  • Bachelor's Degree in Chemistry, Biology, or other technical field.
  • 5-7 years' experience in regulatory affairs in Class I and II products, preferably with laboratory and Point of Care IVD instruments and reagents and/or blood glucose monitoring devices.
  • 3+ years related quality assurance, quality system experience or an equivalent combination of experience and education.
  • 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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