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Associate Regulatory Affairs Engineer
Associate Regulatory Affairs Engineer:
Essential Duties and Responsibilitiesinclude the following. Other duties may be assigned.
* Performing complaint determinations and participating in complaint review meetings.
* Assisting in various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses.
* Composing and submitting mandatory device reports (Medical Device Reports, Vigilance Reports, Mandatory Device Reports) to the appropriate regulatory agencies.
* Assisting the Quality Manager in coordinating product recalls / advisory notices with the appropriate regulatory agencies.
* Performing internal quality audits and effectiveness reviews (FDA’s QSR, ISO 13485, MDD, CMDR).
* Participating in the FDA premarket approval process (PMA) for new and modified medical devices.
* Performs other duties as assigned by Management.
This job has no supervisory responsibilities.
To perform the job successfully, an individual should demonstrate the following competencies:
Analytical- Collects and researches data.
Problem Solving- Gathers and analyzes information skillfully; Works well in group problem solving situations.
Oral Communication- Demonstrates group presentation skills.
Written Communication- Writes clearly and informatively; Presents numerical data effectively.
Business Acumen- Understands business implications of decisions.
Organizational Support- Supports organization's goals and values.
Planning/Organizing- Prioritizes and plans work activities.
Quality- Demonstrates accuracy and thoroughness; Applies feedback to improve performance.
QualificationsTo 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.
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.
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.
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.
To perform this job successfully, an individual should have knowledge of Excel Databases, SQL Reporting, MS Access, and Strong experience with Microsoft Office Suite.
* Experience with the PMA approval process preferred.
* Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred.
Physical DemandsThe 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 EnvironmentThe 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.
Education and/or Experience
Bachelor's degree from four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience.
NO AGENCY CALLS PLEASE
ZOLL is an Equal Opportunity Employer
Pittsburgh, Pennsylvania, United States