B. Braun

  • Sr Regulatory Affairs Analyst

    Job Locations US-PA-Allentown
    Requisition ID
    2018-12352
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Regulatory
    Position Type
    Regular Full-Time
    Shift
    8am to 5pm
    Site
    Allentown, PA
  • Overview

    With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

     

    U.S. Facilities and Operations:

     

    Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

    Responsibilities

    Position Summary:

     

    To plan and prepare registration documents for marketing approval of B. Braun’s drug and device products in the US and in foreign countries under minimal supervision. To be a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.

     

    Responsibilities: Essential Duties

    • Research and analyze requests received from Research and Development, Marketing and International Sales Division.
    • Plan and prepare dossiers for registration of drug and device products such as IND/NDA/ANDA and 510(k)/IDE/PMAS.
    • Participate and provide regulatory input for product development teams.
    • Review, analyze and prepare written assessment for proposed modifications to drug and device products for regulatory impact.
    • Read, review, interpret and keep current with regulations, recognized standards and publications regarding drug and device products.
    • Interact with B. Braun representatives of foreign countries regarding registration of drug and device products.
    • Interact with regulatory agencies concerning regulatory filings with minimal supervision.
    • Provide regulatory guidance to interdepartmental members concerning B. Braun filings
    • Review regulatory documents for submissions to regulatory agencies.
    • Review labeling for accuracy and compliance with regulations.
    • Other duties as assigned.

    Expertise: Knowledge & Skills

    • Ability to read and interpret regulations and guidelines
    • Ability to multi-task.
    • Excellent verbal and written communication skills
    • Skilled in planning, organizing, coordination projects and working independently
    • Ability to use standard computer equipment and software applications (Microsoft office).

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • One to two years experience in Regulatory Affairs or scientific discipline.
    • BA/BS degree in scientific discipline or equivalent experience.
    • Both problem solving, decision making and negotiating skills are required to the extent that regulatory submissions impact B. Braun's product registrations and filings. Critical decisions would be reviewed with supervisor prior to implementation.

    Desired:

    • Experience in preparation of regulatory filings in pharma or medical device settings.
    • Knowledge of ICH, ISO, CTD/eCTD/STED and international regulations.

    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 20 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 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 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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