Associate Regulatory Affairs Engineer

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 purpose

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 or manufacturing process changes. 

Duties and responsibilities

• 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.
• Performs other duties as assigned by Management.

Qualifications

• Bachelor's degree in Engineering or Life Sciences
• 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 desired.
• RAC certification preferred.

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.

Physical requirements

• 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.

Supervisory responsibility

No Direct Supervisory Responsibility

AAP/EEO Statement

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 Veteran

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