C. R. Bard, Inc.

  • Sr. Regulatory Specialist

    Posted Date 4 weeks ago(7/25/2018 2:31 PM)
    Job ID
    2018-11934
    Career Level
    experienced
    Division
    Regulatory Affairs
    Relocation
    No
    Location
    US-RI-Warwick
  • Overview

    BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years, we have stood out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products, our BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties. 

     

    Our company has a strong tradition of developing our employees to learn, grow and excel.  We are continually building our team with qualified, team oriented individuals to enhance the success of our company.

    The Surgery business unit is situated in a central location, surrounded by a scenic coastline with easy access to T.F. Green Airport, AMTRAK Train Stations and Route 95, a major highway connecting to Providence, Connecticut, Boston and New York City within a short amount of time.

     

    Summary of Position with General Responsibilities

    Provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical products regulations. Provide regulatory support to marketed products. The initial focus will be overall execution and implementation of the European Medical Device Regulation (EU MDR) on a business unit level.

    Essential Job Functions

    • Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)’s, IDE’s, PMA’s)
    • Assist in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales).
    • Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.
    •  Prepare applications for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTED).
    • Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.
    • Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.
    • Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy. 
    • Assist in development of new product instructions for use/promotional material.
    • Review product labeling for compliance with medical device regulations and Division/Corporate Policies.
    • Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.

    Basic Qualifications

    • B.S. or equivalent with emphasis on Life Sciences. Professional certifications preferred.

     

    • Knowledge and experience (Minimum 4-6 years) with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files).

     

    • Good oral and written communications skills, analytical thinking and technical writing; ability to work on cross-functional teams.

     

    • Working knowledge of statistics and electronic documentation and information systems.

     

    • Ability and desire to travel as needed.

    Additional Desirable Qualifications Skills and Knowledge

    Master’s degree preferred.

    Education and/or Experience

    BD Interventional and Becton Dickinson are Affirmative Action/Equal Opportunity Employers, M/F/D/V. VEVRAA Federal Contractor.

     

    C. R. Bard, Inc. (NYSE: BCR) 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 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.

    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 and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.

    Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. 

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