B. Braun

  • Regulatory Affairs Intern

    Job Locations US-PA-Center Valley
    Requisition ID
    2019-13873
    Company
    Aesculap Implant Systems
    # of Openings
    1
    Category
    Internship/Co-op
    Position Type
    Intern
    Shift
    8-5
    Site
    Aesculap Implant Systems
  • Overview

    Aesculap Implant Systems, LLC, a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives.

     

    Responsibilities

    Position Summary:

     

    Aesculap’s internship program provides an exciting opportunity for participants to have hands on Regulatory experience in the growing medical device field. Intern will be responsible for regulatory team support, regulatory projects, and other duties as assigned.

     

    Responsibilities: Essential Duties

    • Assists with UDI support for Class II Implants
    • Completes regulatory research
    • Assists with LTF/510(k) submissions
    • Assist with training and other department projects/tasks
    • Prepares and presents end of summer internship presentation to Executive Team.
    • Other duties may be assigned.

    Expertise: Knowledge & Skills

    • Must comply with applicable ISO and FDA regulations as stated in the Quality Manual.
    • Must embody the Company’s Vision, Mission, and Values.

    SUPERVISORY RESPONSIBILITIES:

    • Not Applicable.

    Qualifications

    Expertise: Qualifications-Experience/Training/Education/Etc

     

    Required:

    • Currently enrolled full time in an undergraduate program with a major in Business, Biology or other relevant field. (Junior year preferred)
    • Requires excellent written and interpersonal communication skills.
    • Requires competency in Microsoft Office Word, Excel and PowerPoint.    
    • Language Skills: Proficiency in English language. Ability to read, analyze, and interpret scientific and technical journals, financial reports and business contracts. Ability to respond to common inquires or complaints from customers, regulatory agencies or members of the business community. Ability to effectively present information to team members, management and clients.
    • Mathematical Skills: Ability to perform basic and advanced business math including manipulating spreadsheets in Excel, and creating appropriate graphs.
    • Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions.

    Desired:

     

    While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.

     

     

    Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com Equal Opportunity Employer Minorities /Women/ Veterans/Disabled

     

    Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

    Other

    Responsibilities: Other Duties:

     

    The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

     

    Physical Demands:

    • The employee must occasionally lift and/or move up to 25 pounds.

    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.

     

    Work Environment:

    • The noise level in the work environment is usually moderate.

    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 usually moderate.

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