C. R. Bard, Inc.

  • Regulatory Affairs Associate

    Posted Date 1 week ago(4/10/2018 12:58 PM)
    Industry / Category
    Medical Device/Regulatory Affairs
    Job ID
    2018-11404
    Career Level
    entry level
    Division
    Bard Peripheral Vascular
    Relocation
    No
    Location
    US-AZ-Tempe
  • Overview

     

    Becton, Dickinson Interventional (BDI) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 65,000 people across 50 countries around the world. Founded more than 100 years ago, BDI pioneered many devices that are cornerstones of modern healthcare.  BD - PI is the vascular division within BDI and focusses on interventional products for peripheral arterial disease (PAD), end stage renal disease (ESRD), and Cancer.

     

    We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness, respect, and feel valued, acknowledged and rewarded.

     

    Be Your Best at BD-PI – and ultimately, you can have an impact on the lives of people around the world#LI-SF1

    Summary of Position with General Responsibilities

    This position is responsible for the development and implementation of product registration dossiers in support of international applications. The candidate will be expected to compose, review, and summarize product technical data that is required by regulatory agencies to demonstrate compliance with global regulations and standards. The candidate will be expected to interface and communicate effectively with international business colleagues and regulatory authorities.  Knowledge of international regulatory affairs is preferred.

    Essential Job Functions

    1. Ensures adequate documentation of Bard Peripheral Vascular’s compliance to worldwide regulations and standards.
    2. Prepares and supports international submissions and international product releases in accordance with applicable SOPs.
    3. Maintains regulatory affairs files.
    4. Develops working relationships with key personnel at the division and representatives of international business centers as well as with ministries of health.
    5. Participates in new product development teams, as required, to ensure the product is in compliance with all internal and external worldwide regulatory requirements. Reviews, documents, and supports a worldwide regulatory strategy in support of product development goals.
    6. Represents Bard Peripheral Vascular in corporate working groups.

    Basic Qualifications

    1. Ability to plan and schedule multiple priorities in a concurrent fashion.
    2. Ability to review, collate, and summarize scientific and technical data.
    3. Ability to handle master documents, drawings, and specifications with a high degree of confidentiality.
    4. Excellent problem solving and analytical skills.
    5. Excellent written and oral communication skills.
    6. Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy.
    7. Complete work with minimal supervision and have the ability to work independently.
    8. Knowledge of U.S. and/or international medical device regulations preferred. 

    Education and/or Experience

    1. This position requires a Bachelor’s Degree in Law, Engineering, or one of the Life Sciences, or similar education or experience.
    2. The incumbent may have 0-1 year experience in a regulatory affairs, or documentation environment, or related field.  Experience in International Regulatory Affairs is preferred.
    3. Knowledge of a second language is preferred.

    Physical Demands

    While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

    Work Environment

    While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

     

     

    #LI-SF1

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