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The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest® wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies.
Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives.
ZOLL has been Pittsburgh’s Manufacturer of the Year, one of Western PA’s Healthiest Employers, and even one of Pittsburgh’s Coolest Offices. But it’s our unique opportunity to impact people’s lives that makes ZOLL the ideal place to build your career.
This position will be responsible for the preparation and submission of US regulatory applications for medical devices including 510(k)s, IDEs, PMAs, PMA Supplements, and Annual Reports, as well as international regulatory applications and device approvals. This position will provide expertise, recommendations, and regulatory direction for new product development, and product design modifications and manufacturing changes
Duties and responsibilities
Prepare and submit IDEs, PMAs, PMA Supplements, and Annual reports to FDA and interact with FDA reviewers to gain marketing approval.
Prepare and submit international registrations and device applications and interact with global partners.
Provide regulatory intelligence to support marketing applications.
Perform regulatory assessments of product modifications.
Review product labeling and provide input.
Establish and maintain design dossiers and technical files.
Performs other duties as assigned by Management.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
The noise level in the work environment is usually quiet.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit, talk, and hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.
No Direct Supervisory Responsibility
Education and/or Experience
Bachelor’s degree in Engineering or Life Sciences
3 or more years of medical device experience
Experience with PMAs and 510(k)s preferred
International device approval experience preferred.
Project management experience desired.
RAC certification preferred.
ZOLL is committed to fostering an inclusive workplace, where unique identities, backgrounds, cultures, perspectives, and experiences are respected and valued.
Equal Opportunity Employer – Disability and Veterans
Internal Number: 1234
About ZOLL Cardiac Management Solutions
The LifeVest® wearable cardioverter defibrillator (WCD) is designed to protect patients at risk of sudden cardiac death (SCD), when a patient’s condition is changing and permanent SCD risk has not been established.
While some defibrillator devices are implanted under the skin, the LifeVest WCD is worn directly against the patient’s skin. It is lightweight and easy to wear, allowing patients to return to most of their daily activities with peace of mind that they have protection from SCD. LifeVest is designed to detect certain life-threatening rapid heart rhythms and automatically deliver a treatment shock to save a patient’s life.
LifeVest is used for a wide range of patients, including those who have a reduced heart function following a heart attack, before or after bypass surgery or stent placement, or for those with cardiomyopathy or heart failure that places them at particular risk. On any given day, tens of thousands of people around the world have protection from SCD by wearing the LifeVest WCD