Regulatory Specialist

Location: Eden Prairie, MN

CHF Solutions is an early stage company focused on commercializing the Aquadex FlexFlow system. Our objective is to improve the quality of life for patients with heart failure and related conditions, such as fluid overload. At CHF Solutions, we are committed to the relentless pursuit of identifying and developing innovative solutions to address unmet clinical needs with the goal of benefiting patients, medical practitioners, and the broader healthcare community.

CHF Solutions is seeking a Regulatory Specialist. This position is responsible for actively contributing to the development of regulatory strategy, preparation of submissions, supporting new product development, maintaining regulatory compliance of products/organization and interface with worldwide regulatory bodies.

Position Responsibilities           

  • Ensure compliance to applicable regulatory standards/requirements (FDA Quality System Regulations, European Quality Standards (e.g. ISO 13485), Medical Devices Directive, etc.)
  • Develop regulatory strategy and identify deliverables list for new product submission and design changes with guidance as needed
  • Support Clinical Research in preparation of documents such as clinical protocols, informed consent materials, patient education materials, training materials, and physician information
  • Act as a regulatory representative on product development teams, communicating regulatory requirements and impact of regulations to the development team
  • Prepare FDA, EU and other worldwide regulatory submissions (e.g. applications, IDE Supplements, Change Notifications, Annual Reports, etc.) and other regulatory related documentation (e.g. Declaration of Conformity, Export Notifications, etc.)
  • Review significant product submissions with manager and negotiate submissions issues with agency personnel. Resolve potential regulatory issues and questions from regulatory agencies
  • Provide support for currently marketed products as necessary, including review of engineering changes, process changes, labeling changes, and marketing materials.
  • Act as regulatory representative in internal and external meetings
  • Maintain regulatory systems that overlap with Quality Systems, such as complaint handling and reporting, implant/tracking registries, and labeling

Qualifications

  • BS/BA in technical field or scientific discipline (i.e. biology, engineering, or physical science).
  • 5 years of medical device industry experience with Class II and Class III devices
  • 2-5 years of US and International regulatory experience (EU, Canada, Australia desired) development experience, including 510(k), IDE, and technical file maintenance.
  • Demonstrable direct and effective working relationship with worldwide regulatory bodies
  • Extensive knowledge of standards and regulations with ability to integrate into projects
  • Demonstrated ability to develop strong and appropriate consultant relationships

How to Apply: If you are interested in applying for this position, email your cover letter and resume to
hr@chf-solutions.com.

Please indicate the position that you are applying for and the Requisition ID.

Requisition ID:
17-027

CHF Solutions, Inc. is an equal opportunity employer.