Associate Regulatory Affairs Engineer
|Location:||Gamma Dr. Pittsburgh, PA|
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
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:
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.
ZOLL is an Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity.
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