Regulatory Affairs Project Manager - Minneapolis, MN

ARKRAY is currently hiring a Regulatory Affairs Project Manager to manage programs and processes assuring regulatory compliance of ARKRAY products. Duties and Responsibilities Prepare and submit regulatory applications including 510(k) and CLIA Waiver. Negotiate with FDA on regulatory applications and approvals. 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. Report to management on status, plans and strategies to obtain product approvals in US. Maintain regulatory product files to ensure compliance with regulatory requirements. Prepare printed materials including user manuals, product inserts, product labeling and other technical documentation. Review promotional material, product changes and documentation changes to ensure compliance to FDA regulations. Oversee post market surveillance of currently marketed products through review of customer complaints and MDRs, and management of risk review files. Knowledge and Skills: Bachelors Degree in Chemistry, Biology, or other technical field. 3-5 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. 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.