Regulatory Specialist - Labeling

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 :

• Serve as the labeling SME within the company under the direction of the RA Director or designee
• Work with Regulatory, Development, Quality, Operations and IT to develop / create labeling that complies with global and UDI labeling regulations and requirements, as required
• Serve as the lead team member for labeling initiatives, including but not limited to :
• new product development, maintenance projects, and UDI tasks associated with product labels, package inserts / eIFUs, and patient cards
• Initiate change requests for new and revised labeling; create, maintain, and implement compliant labeling, review product labeling against indicated content, and approve / release labeling documentation for label system usage
• Coordinate effectively with vendors and suppliers of services (e.g., translation vendors, eIFU hosting, UDI systems (ex.

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.)

• Ability to build strong relationships, work effectively and efficiently with cross functional team members to create and implement labeling changes
• Proficient in the use of labeling software (ex. Prisym, Loftware, ROBAR, IQVIA, InDesign, Qarad)
• Knowledge and solid understanding of global labeling regulations and requirements, and a commitment to learn and stay abreast of medical devices regulations
• An understanding of orthopedic / medical devices and their use relating to labeling, design change control, and document control and management
• Must have excellent written and oral communication and technical writing skills.
• Must be analytical and able to solve problems.
• Must possess exceptional attention to detail, organization, and multi-tasking skills.
• Demonstration of strong problem-solving skills; able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner

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.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.

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.