Regulatory Relations Liaison is responsible for filing necessary applications and handling all government interactions pertaining to the regulation and certification process for a plant or other facility. Develops procedures to ensure regulatory compliance. Being a Regulatory Relations Liaison prepares reports for top management detailing projects that may impact the organization's regulation status. May represent the organization before federal or state legislations. Additionally, Regulatory Relations Liaison requires a bachelor's degree. Typically reports to a manager or head of a unit/department. The Regulatory Relations Liaison typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Relations Liaison typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
GENERAL SUMMARY : This position is responsible for managing medical device labeling projects and workstreams (including, but not limited to product labels, package inserts / IFUs, patient cards, translations, labeling systems, GS1 / GTIN, GMDN and UDI initiatives) as necessary to market OrthoPediatrics products in compliance with applicable global regulations and standards.
It requires a broad understanding of medical device regulations (ex. US, EU, Canada, Australia), label and IFU development, change management systems / procedures / concepts, and labeling systems.
This position must have the ability to work effectively and efficiently with all team members, have a good understanding of global labeling regulations and requirements.
Strong attention to detail, written and oral communication, teamwork, and organizational skills are essential, as well as an understanding of Orthopediatrics products and their use.
This position will also provide support during internal and external audits and reviews. Prior experience is a plus.
ESSENTIAL FUNCTIONS :
GUDID, EUDAMED), instrument and / or implant suppliers) to ensure high quality and accuracy of content
SUPERVISORY RESPONSIBILITIES : There are no supervisor responsibilities with this position.
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 : Requires a bachelor’s degree in a technical area with a minimum of 1 year of experience in a labeling capacity, or 2 years of equivalent experience in a related regulatory role in a device industry.
LANGUAGE SKILLS : Ability to read and comprehend instructions, correspondence, and memos. Ability to prepare routine reports and correspondence.
Ability to communicate effectively with customers, vendors and other employees of the organization. Requires excellent grammar and spelling.
Mathematical Skills : Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Reasoning Ability : Ability to carry out instructions furnished in written, oral, or diagram form. Ability to use critical thinking to deal with problems involving multiple variables in a variety of situations.
Certificates, Licenses, Registrations : Requires a valid driver’s license.
Other Skills and Abilities : Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, fax, photocopier, telephone, cell phone, etc.
Requires proficiency with Must be fluent in MS Office (Microsoft Word, Excel, Outlook and PowerPoint).
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 use hands to finger handle or feel .
The employee is frequently required to climb stairs, talk and hear. The employee is occasionally required to stand; walk;
reach with hands and arms; and stoop, kneel, crouch , or crawl . 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 that found in a normal office environment; noise levels during visits to other locations in the building may be moderate and occasionally loud.
The employee will be required to travel 25% of the time.
The above statement reflects the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.
Last updated : 2024-04-23
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