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Associate Regulatory Affairs Engineer

Location: Gamma Dr. Pittsburgh, PA

Description

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.

 

Position Summary:

  • This position will be responsible for the preparation and submission of domestic regulatory applications for a class 3 PMA medical device including IDEs, PMAs, PMA Supplements, and Annual Reports.  This position will also be responsible for international regulatory applications and device approvals.  This position will provide expertise, recommendations, and regulatory direction for new product development, advertising and promotional materials, and product design modifications or manufacturing process changes.  This position will coordinate product recalls both domestically and internationally. A Bachelor's degree in Bio-Engineering/Biomedical Engineering is required.

Essential Duties and Responsibilities

  • Investigation of medical device complaints and, prepare and submit corresponding incident reports to FDA and/or international regulatory bodies for device malfunctions and adverse events.
  • Prepare and submit IDEs, PMAs, PMA Supplements, and Annual reports to FDA.
  • Interact with FDA and/or international regulatory bodies to gain marketing approval. 
  • Conduct various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses.
  • Post-Market surveillance data analytics.
  • Prepare quality procedures and work instructions.
  • Prepare, submit, and coordinate product recall notifications, advisory reports, and incident reports.
  • Performs other duties as assigned by Management.

Supervisory Responsibilities                                                                                                                                          

None.

Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience                                                        

  • Bachelor's degree in Bio-Engineering/Biomedical Engineering is required.
  • Strong experience working with Microsoft Office Suite.
  • PMA approval process experience preferred. 
  • International device approval experience preferred.
  • Medical device risk management preferred.
  • MS Access database experience preferred.

Language Skills                                                                 

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Strong writing skills where information is effectively presented in a clear and concise manner to groups of managers, clients, customers, regulatory bodies, and the general public.

Mathematical Skills                                                         

Ability to work with mathematical concepts such as probability and statistical inference.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability                                                             

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Physical 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; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

Work Environment 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 an Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity.

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