Beaver Visitec International

  • Regulatory Affairs Manager

    Job Location US-MA-Waltham
    Posted Date 1 month ago(7/18/2018 3:05 PM)
    # of Openings
    1
  • Overview

     

    Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

     

     

    Currently seeking to hire: Regulatory Affairs Manager As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

     

    Responsibilities

      

     Reporting to the Vice President of Quality & Regulatory, the Regulatory Affairs Manager assists in leading the regulatory function for BVI's global operations. Will work with the senior leadership and country managers to define likely regulatory pathways and devise strategies to align development activities with the same. Participates and provides guidance and support to other business functions on all regulatory matters. Prepare documents for interactions with US and International regulatory agencies as well as distributors as the business requires.  As compulsory, will evaluate product circulars and labeling to ensure that performance claims and wording are appropriate to regulations. Responsible for international registration activities, including the notarization, legalization, and apostilling of relevant documents per country requirements.  Prepares and files 510(k) s. Manages technical files (dossiers), Declaration of Conformities and other documentation such as CERs as necessary. Works with document control. Manages one or two Regulatory Specialists and may manage temporary and/or consultant resources.  Provides some regulatory counsel to internal groups such as Marketing, Sales and R&D on routine basis, and will consult with BVI's KOL's as needed.  Manages ongoing registration / re-regulation of existing countries and new countries .Prepares submissions to obtain and maintain global regulatory approvals. Conduct VOC at Ophthalmic conferences as needed.

    Qualifications

      .

     REQUIRMENTS:  BS or BA degree.  The ability to create and organize technical/regulatory documentation.  5-7 years of experience working in a Medical Device company.  Knowledge of clinical and regulatory requirements for the testing and sale of medical products.  Ability to manage multiple projects and priorities.  A minimum of two years of people management experience. Proficiency with Microsoft Office.    

    Preferred: MS Degree COT, RAPS certification; Experience working in the ophthalmic medical device industry in a regulatory-related position.  

    Sitting, standing, presenting, lifting up to 35 lbs. unassisted. Ability to work on a computer and travel by plane/car/train.  Up to 5-10% travel domestically and internationally.

    Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

     

     

    The ability to create and organize technical/regulatory documentation.   5-7 years of experience working in a Medical Device company. Knowledge of clinical and regulatory requirements for the testing and sale of medical products. Ability to manage multiple projects and priorities. A minimum of two years of people management experience.

     

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