ABOUT MEDRHYTHMS

MedRhythms is a leading digital therapeutics company, with a focus on creating FDA-cleared prescription products with a focus on improving mobility through music, sensors, and artificial intelligence. The company’s approach is to integrate MedRhythms’ products with previously approved pharmaceutical drugs, other treatment modalities, and stand-alone therapeutics to provide better outcomes for patients, data and insights for clinicians and partners, and cost-effective solutions for payers. Our vision is large! And we have brought together a passionate team of individuals who are committed to fulfilling our mission and making a big impact in the world. MedRhythms has been mentioned in Forbes, The Huffington Post and Xconomy.


OVERVIEW

The Clinical and Regulatory Manager (CRM) will lead the strategy and implementation of all clinical trials (proof of concept through pivotal) and regulatory processes for MedRhythms trials.  This will Include sourcing, developing and managing new sites, drafting IRB submissions and maintaining study documents and budgets.   Additionally, the CRM will lead all interactions with the FDA, from submission to approval and work to appropriately align clinical strategy, regulatory strategy and internal priorities.  The CRM serves as a liaison between MedRhythms, clinical collaborators, Principal Investigators and regulatory bodies.


RESPONSIBILITIES

  • Support the regulatory pathway for the MedRhythm’s Stride and Stride Plus products by overseeing clinical research and regulatory affairs, including the following:

    • Work with regulatory consultants to lead all interactions with the FDA (submissions, meetings, listing of devices, post-market activities)

    • Source, secure and set-up clinical study sites for pivotal trial

      • IRB Submissions

      • Hospital Contracts

      • Supply Procurement

      • Staff Training

    • Monitor all study sites

      • Maintain ongoing status of each Study Subject

      • Audit all study documents according to MedRhythms Monitoring Procedures

      • Ensure ongoing analysis and storage of data

    • Track all research expenses for clinical studies and review budget monthly with management

    • Serve as subject matter expert in regards to protocols, regulatory compliance and clinical partners

    • Monitor compliance with all local and federal regulators

      • Maintenance of IRB and FDA Correspondence Indexes

    • Manage internal communication (lead weekly management meeting during pivotal trial) to ensure project milestones are met toward clearance

  • It is the responsibility of every employee at MedRhythms to adhered to the requirements of the established Quality Management System

  • Manage the product pipeline as it relates to regulatory, including proof of concept, feasibility, and pilot trials for other neurologic conditions


Requirements

  • Bachelor’s degree

  • Meticulously organized

  • High level of integrity

  • Exceptional time management and prioritization skills

  • Excellent communication skills to interface with patients, clinicians, and regulators

  • Empathetic “bed side manner”

  • Ability to communicate requirements internally with management and product developers

  • Ability to negotiate and influence others

 


Nice to Have

  • Regulatory Affairs Certification (RAC)

  • Demonstrated competence in FDA 21.CRF 820 and ISO 13485

  • Experience with Key Opinion Leaders (KOL)

  • Experience supporting cleared medical device

 


How to Apply

To apply for this position, please email careers@medrhythms.com with your resume and a brief cover letter that includes your relevant experience and why you think you would be a good fit for MedRhythms.