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Since 1985, our core business has been enteral device product development, design, manufacturing, and engineering in a state-of-the-art facility near Cleveland, Ohio. AMT’s steady growth consistently creates job opportunities in Northeast Ohio. We are always searching for new talent and would love for you to join our team! We strive to keep the small company feeling while still reaching users all over the globe.
Position Summary:
This position is responsible for revising labels, directions for use, and other documentation for submission to various regulatory agencies - most notably those pertaining to the European Medical Device Regulation. Additionally the position will help maintain and improve upon international compliance. Candidate must possess the ability to work well in a team environment and demonstrate great attention to detail.
Duties and Responsibilities:
This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties may be assigned.
Supervisory Responsibilities: None
Minimum 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/Communication Skills: Ability to communicate across functions, professional levels and background.
Computer Skills: Intermediate to advanced knowledge of Microsoft Office Suite.
Essential Job Functions: Critical features of this job are described below. They may be subject to change at any time due to reasonable accommodation or other reasons.
Mental: Must be able to effectively communicate with others; complete and understand complex situations, analysis of numbers; read, analyze and interpret written materials; work with team to meet and exceed company standards; ensure compliance with company policies; respond appropriately to feedback to make improvements; maintain positive working relationships; troubleshoot and solve problems.
Physical: Must be able to communicate for hours at a time, use computer equipment. Moderate noise level and limited exposure to physical risk.
Knowledge, Skills, and Abilities Required: Knowledge of modern business communication, office procedures and methods. Skill to use a personal computer and various software packages such as Microsoft Office Suite. Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork.
Equipment Used: Telephones, computer, other office equipment as needed.
Special/ Additional Requirements: Persons in this position may be required to pass a drug, alcohol, and/or criminal background check.
AMT is Equal Opportunity/Affirmative Action Employer
Benefits:
Other Exciting Perks!
Full Time
Medical Technology
$76k-98k (estimate)
06/10/2024
06/30/2024
appliedmedical.net
BRECKSVILLE, OH
100 - 200
1986
Private
GEORGE J PICHA
$5M - $10M
Medical Technology
Applied Medical Technology designs, develops and manufactures medical devices for enteral feeding.
The following is the career advancement route for Regulatory Affairs Specialist positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Specialist, it can be promoted into senior positions as a Regulatory Affairs Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Specialist. You can explore the career advancement for a Regulatory Affairs Specialist below and select your interested title to get hiring information.