• Regulatory Affairs Specialist

    Posted Date 3 months ago(5/2/2018 10:53 AM)
    Job ID
    2018-1945
    Job Location
    US-GA-Kennesaw
    # of Openings
    2
    Category
    Regulatory Affairs
  • Introduction

    Is This The Role For You?

     

    We hire smart people with big hearts.  People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role.

     

    If you’re ready for a career that allows you to grow and develop into the professional you want to be – today and in the future….CryoLife is the place for you.

    Position Overview

    The Regulatory Affairs Specialist works directly with the Regulatory Affairs Managers and/or Director to assist with regulatory submissions, primarily Tier II country submissions. In addition, the RA Specialist will provide support for country and state licensing activities and assist with responses to the FDA and other regulatory agencies as needed.

     

    Responsibilities

    • Conduct Tier II regulatory agency submissions.
    • Assist with domestic and international regulatory agencies 510(k), IDE, PMA, HDE, IND, BLA, CE dossiers, supplements, and responses.
    • Prepare state licensure/certifications, export certifications, product registrations, etc. for review by RA management.
    • Identify and collect information critical to submission packages
    • Keep RA management informed of critical information that may impact departmental goals and/or responsibilities.
    • Submit FDA establishment reports and country license renewals.
    • Submit tissue bank license renewals and country annual reports, with guidance.
    • Other functions as assigned.
    • Assist with post-acquisition tasks.

     

    Qualifications

    • Bachelor’s degree in Biology or related field or equivalent experience.
    • 0-2 years of experience in the device regulatory affairs or related field is preferred.
    • Ability to take direction, work well with others, and able to work independently.
    • Strong written and verbal communication skills are required.
    • Strong computer skills, i.e. word processing, spreadsheets, data analysis.
    • Ability to maintain high activity level, effectively manage and prioritize numerous projects and responsibilities.

    Company Info

    Who We Are.

     

    CryoLife is one of the world’s contemporary medical device companies providing preserved human cardiac and vascular tissues, surgical adhesives and sealants, cardiac lasers and implantable end-stage renal disease access grafts for the repair of complex cardiac and vascular reconstruction surgeries. Since the Company’s inception in 1984, it is estimated that its products and tissues have been implanted in about 900,000 patients worldwide.

     

    CryoLife technology and products bring restoration and hope to people all around the world. CryoLife headquarters are located in Kennesaw, Georgia, a suburb of Atlanta.

     

    CryoLife is an Equal Opportunity/Affirmative Action employer.

    CryoLife is committed to the philosophy of equal opportunity employment. We do not discriminate against any employee or applicant.  All qualified candidates will receive consideration for employment without regard to race, ethnicity, age, religion, sex, sexual orientation, national origin, citizenship, disability, veterans or other legally protected status.

     

    Reasonable Accommodations
    CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email ADA_Accommodation@CryoLife.com or call 770-429-5215. A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.

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