Regulatory Affairs Associate

About the Company:

Magenta is a medical device company developing the world’s smallest heart pump, meant to provide minimally-invasive support to the heart during acute episodes of dysfunction. The Elevate™ System is multi-disciplinary, involving mechanical engineering, material science, electrical engineering, software, algorithms and state-of-the-art catheter fabrication techniques.

We are looking for the best people possible who can help us propel the Elevate™ System forward and save more lives.

About the Role:

We are seeking an experienced Regulatory Affairs Associate to join our team. The Regulatory Affairs Associate will support Magenta’s products from early feasibility through marketing authorization, ensuring compliance with regulatory requirements. This role will work closely with other departments to maintain regulatory adherence and facilitate successful product approvals.

Responsibilities:

• Provide regulatory support for Magenta’s products from early feasibility through marketing authorization.
• Prepare and maintain regulatory submissions and registrations for Magenta’s products in relevant markets.
• Conduct technical reviews of data and reports for regulatory submissions to ensure accuracy and clarity.
• Assess changes to device design or processes to determine their impact on pending or existing registrations.
• Provide guidance to project teams on premarket regulatory requirements, labeling standards, and other compliance matters.
• Monitor and communicate updates on new or revised guidance, regulations, and industry initiatives to ensure regulatory compliance.

Qualifications:

• Bachelor’s degree in a scientific, technical, or engineering discipline – must.
• Minimum of five years of Regulatory Affairs experience with the US FDA and EU regulatory agencies (Class II and/or Class III medical devices) – must.
• Alternatively, candidates with a strong background in Design Quality Assurance seeking to specialize in Regulatory Affairs will be considered.
• Excellent writing and editing skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Proficiency in standard MS Office applications.
• Fluency in English, both oral and written.