What are the responsibilities and job description for the Regulatory Inern position at OrthoPediatrics?
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 53 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 70 countries outside the United States. For more information, please visit www.orthopediatrics.com.
GENERAL SUMMARY: The Intern will be responsible for providing general regulatory, clerical, and administrative assistance for the Regulatory and Clinical Affairs team while also gaining on-the-job training that will assist him/her with his/her future career search.
Essential Functions
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.)
LANGUAGE SKILLS: Ability to read and comprehend instructions, correspondence, and memos. Ability to communicate effectively with team members, internal customers, 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 apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Regulatory Affairs Intern
Job Description
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 Microsoft Word, Excel, Outlook and PowerPoint.
PHYSICAL DEMANDS: (The physical demands described here are representative of those that must be met by an Intern 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 Intern is regularly required to sit and use hands to finger, handle or feel. The Intern is frequently required to climb stairs, talk and hear. The Intern is occasionally required to stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. The Intern 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 Intern 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 Intern occasionally performs work related to travel.
The above statement reflects the general details necessary to describe the principal 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.
GENERAL SUMMARY: The Intern will be responsible for providing general regulatory, clerical, and administrative assistance for the Regulatory and Clinical Affairs team while also gaining on-the-job training that will assist him/her with his/her future career search.
Essential Functions
- Gain knowledge of OP medical devices and governing regulatory requirements.
- Assist in the research and compilation of registration documentation.
- Assist in the research, assessment and analysis of changes impacting regulatory status of OP devices.
- Participate on and assist the Regulatory team for Regulatory-driven projects and work-streams
- Data management (compilation, verification, gap-analysis)
- Initiation/creation of infocards and change requests in the OP document management system
- Gain knowledge of OP medical devices and governing regulatory requirements.
- Partner with cross-functional team members in the performance of daily activities, including Quality, Operations, Engineering, and Sales.
- Assist in 3rd Party Audit activities by supporting backroom leader (document pull, runner, logistics coordination)
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.)
- Excellent verbal and written communication skills
- Able to work independently or on teams
- Easily adapts to new technology and applications
- Experience using office software tools and applications
- Ability to work with minimal to moderate supervision
- Ability to manage multiple projects and deadlines
- Problem solving skills required
LANGUAGE SKILLS: Ability to read and comprehend instructions, correspondence, and memos. Ability to communicate effectively with team members, internal customers, 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 apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Regulatory Affairs Intern
Job Description
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 Microsoft Word, Excel, Outlook and PowerPoint.
PHYSICAL DEMANDS: (The physical demands described here are representative of those that must be met by an Intern 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 Intern is regularly required to sit and use hands to finger, handle or feel. The Intern is frequently required to climb stairs, talk and hear. The Intern is occasionally required to stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. The Intern 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 Intern 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 Intern occasionally performs work related to travel.
The above statement reflects the general details necessary to describe the principal 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.
