Principal Regulatory Affairs 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. We are seeking a Principal Regulatory Affairs Specialist for our Eden Prairie, MN location.
This individual 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.
- 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 for new product submissions and design changes with guidance from senior regulatory staff, as appropriate.
- 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, Design Dossier Amendments, Annual Reports, etc.) and other regulatory related documentation (e.g. Declaration of Conformity, Export Notifications, etc.).
- Resolve potential regulatory issues and questions from regulatory agencies. Negotiate submission issues with agency personnel.
- Provide support for currently marketed products, including review of engineering changes, process changes, and labeling changes.
- Support Clinical Research in preparation of documents such as clinical protocols, informed consent materials, patient education materials, training materials, and physician information.
- 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
- BS/BA in technical field or scientific discipline (i.e. biology, engineering, or physical science).
- 7+ years of medical device industry experience with cardiovascular experience preferred.
- 5+ years of US and international regulatory experience (EU & Asia desired).
- Demonstrable direct and effective working relationship with worldwide regulatory bodies.
- Demonstrable experience developing and interpreting standards, guidelines and special controls.
- Extensive knowledge of standards and regulations with ability to integrate into projects.
- Demonstrated ability to develop strong and appropriate consultant relationships.
- Experience with both large and start-up companies; ability to translate experiences into practical course of action in a start-up environment.
- Ability to think independently and make sound strategic regulatory decisions.
How to Apply: If you are interested in applying for this position, email your cover letter and resume to firstname.lastname@example.org. Please indicate the position that you are applying for and the Requisition ID.
Requisition ID: 18-049
CHF Solutions, Inc. is an equal opportunity employer.