Reference #: R12850
CMS, Softaid.localAt ZOLL, we're passionate about improving patient outcomes and helping save lives.We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.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.Job SummaryThis 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 or manufacturing process changes.Essential Functions
Prepare and submit IDEs, PMAs, 510(k)s, 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.
Coordinating with teams across R&D, clinical, quality, and manufacturing.Required/Preferred Education and Experience
Bachelor's Degree in Engineering or Life Sciences required
1-3 years Of medical device experience preferred
Experience with the PMAs and 510(k)s preferred
International device approval experience preferred
Project management experience preferred
RAC certification preferredPhysical Demands
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 and talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.Working Conditions
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 the essential functions.
The noise level in the work environment is usually quiet.ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
#LI-KH1All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.ZOLL LifeVest is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.