Associate Regulatory Affairs Engineer
Company Name:
Zoll LifeVest
Location: Gamma Dr. Pittsburgh, PA
Department: 2110 Quality Assurance
Description
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 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.
Essential Duties and Responsibilities
Prepare and submit IDEs, PMAs, PMA Supplements, and Annual reports to FDA and interact with FDA reviewers to gain marketing approval.
Conduct various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses.
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 Engineering or Life Sciences
Knowledge of Excel Databases, SQL Reporting, MS Access, and strong experience with Microsoft Office Suite.
Experience with the PMA approval process preferred.
International device approval experience preferred.
Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. 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.
PI91425738Estimated Salary: $20 to $28 per hour based on qualifications.
Zoll LifeVest
Location: Gamma Dr. Pittsburgh, PA
Department: 2110 Quality Assurance
Description
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 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.
Essential Duties and Responsibilities
Prepare and submit IDEs, PMAs, PMA Supplements, and Annual reports to FDA and interact with FDA reviewers to gain marketing approval.
Conduct various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses.
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 Engineering or Life Sciences
Knowledge of Excel Databases, SQL Reporting, MS Access, and strong experience with Microsoft Office Suite.
Experience with the PMA approval process preferred.
International device approval experience preferred.
Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. 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.
PI91425738Estimated Salary: $20 to $28 per hour based on qualifications.
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