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.All qualified candidates located within the continental United States will be considered.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, specifically 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.
ARKRAY USA, Inc.