February 28, 2019
This is an opportunity to join a dynamic start-up that is poised to revolutionize the clinical practice for patients with advanced heart failure.
Endotronix, a growing medtech company located in Lisle, IL just outside Chicago, is advancing the treatment of heart failure (HF) with proactive data-driven solutions that improve the quality of life for patients and clinicians. The company’s platform streamlines care for patients with advanced heart failure. It is comprised of an intuitive patient management system and a wireless, implantable sensor to manage HF patients’ pulmonary artery pressure, a leading indicator for early detection of worsening heart failure. The comprehensive solution overcomes inefficiencies in managing these complex patients and extends clinical care into the home.
About the role
Senior Regulatory Affairs Associate
The Sr Regulatory Affairs Associate demonstrates quality in all actions; Participates in cross-functional team meetings. Provides regulatory guidance and support. Consults with regulatory manager or director to establish and prepare appropriate regulatory filings for product approvals. Maintains current and in-depth knowledge of FDA, European and Worldwide Regulatory Authority programs, policies and other critical regulatory information. Assists in the development and execution of effective regulatory affairs strategies with team representatives and with the Manager or Director of Regulatory Affairs. Provides input and prepares the clinical regulatory packages.
Essential duties and responsibilities
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. Coordinates activities concerned with the submission and approval of medical device products to government regulatory agencies by performing the following duties:
- Assists in the development of worldwide regulatory strategies and filings for product approvals.
- Provide regulatory support to cross-functional project teams in conjunction with direct manager.
- On a project team, makes decisions involving worldwide submissions and provides advice and counsel to other team members with the assistance of direct manager.
- Assist and/or prepare and submit FDA submissions (e.g., IDEs, PMAs, HDEs, Progress reports, UADEs, device listing).
- Assist and/or prepare dossiers for submission to worldwide regulatory agencies (e.g., Latin America, Asia Pacific).
- Reviews and approves change requests and Change Orders.
- Maintains current knowledge of FDA, European and Worldwide Regulatory Authority programs, policies and guidelines.
- Assures that all submission documentation, record keeping and reporting meet inspection standards as established by regulatory agencies worldwide.
- Assist in the process for the development and release of labeling materials (Instructions for Use and patient materials) intended for users of Endotronix products.
- Assist in coordinating and executing all activities necessary including proofreading, translation management, and release of labeling. Ensures all labeling materials are designed in accordance with company and regulatory standards.
- Maintains current and in-depth knowledge of FDA, European and Worldwide medical device regulations related to labeling.
- 6-8 years of Regulatory experience with a Medical Device Company, preferably a Class III (US and EU) medical device
- BA/BS in a Life or Physical Science or equivalent.
- Ability to develop and maintain excellent working relationships with regulatory agencies / bodies.
- Excellent written and verbal communication skills.Microsoft Office.
- Knowledge of U.S. and European medical device regulations.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the U.S. and to complete the required verification document upon hire. Endotronix participates in E-Verify.
Interested? Click here to begin applying now.