• Certification Specialist (Active Implantable Medical Devices)

    Location(s) US-VA-Herndon
    Category
    Healthcare
    Contract Type
    Perm Full-Time
    Closing Date
    9/7/2018
  • About the Role

    BSI is hiring a Certification Specialist to work in our Herndon, VA office. This individual will be part of our Global Medical Device team, responsible for helping our clients through the regulatory process for bringing medical device products to market. This is a great time to join a growing team full of professionals who are passionate about patient safety and delivering superior services to our customers. 

     

    The Certification Specialist is responsible for managing the Medical Device ISO 13485 certification scheme within the dedicated medical device technology team. ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. This position will support the Active Implantable Medical Device (AIMD) team which is comprised of subject matters experts in implantable cardiac pacemakers, implantable defibrillators, implantable neurostimulator systems, cochlear implants, implantable infusion pumps, implantable glucose monitors and more. 

     

    The ideal candidate will already be familiar with product certification concepts, medical devices, regulatory affairs, internal auditing, and quality management. This role involves administrative duties, internal and external customer service, and a strong technical understanding of quality standards and product certification. This is an entry to mid-level role designed for candidates with 3-10 years of relevant experience. 

     

    Job Duties:

    • Deliver Medical Device ISO 13485 scheme management as a fully integrated member of a Medical Device Technical Team
    • Take ownership of the ISO 13485 Scheme, and respond to client enquiries relating to that scheme as the main point of contact
    • To conduct quotation reviews, contract reviews, process applications, and compile Certification Decisions under the ISO 13485 certification scheme
    • To support the delivery of the surveillance audits and implement any certificate changes, renewals under the ISO 13485 scheme
    • Support CE-Marking Scheme Management (under supervision) within the technology team. Tasks include, but are not limited to, minor changes to CE certificates, or activities that do not require prior medical device product knowledge
    • Compile CE Marking Certification Decisions under the supervision of the scheme manager
    • To monitor work in progress and keep clients informed of completion dates for certification and certification related activities
    • Support the Technology Team Global Head in the smooth running of the team’s operation
    • To support the process of qualifying external experts whose services may be required in the BSI CE certification process
    • If required under the individual’s operations objectives, provide support to the Client Service Cooordination Team to prepare and issue annual service management orders, and contracts to internal and external suppliers of product testing and continuing assessments
    • To invoice for services according to scales of fees published by BSI
    • To maintain accurate records of activities, and individual competency records that meet regulatory and BSI procedural requirements

    About You

    This role is designed for someone who is highly professional, highly ethical, customer focused, genuinely interested in quality management, and very capable of learning technical concepts. This role requires excellent organization skills, time management and prioritization skills, effective communication skills, and ability to thrive in a regulated and challenging environment where your contributions are valued. 

     

    Please carefully review the qualifications listed below and apply if you meet the criteria.

    Qualifications:

    • Bachelor's degree (or equivalent experience) in engineering, science, medical, quality or other related field.
    • Possess understanding of quality managmeent principles, quality management certification process, and CE Mark.
    • Familiarity with Active Implantable Medical Devices
    • Previous experience in customer service and project management. Regulatory experience preferred. 
    • Strong computer skills (Windows, Microsoft Excel, Outlook, and Word) and the ability to learn BSI software systems.

     

     

    About BSI

    Do you believe the world deserves excellence?

    BSI (British Standards Institution) is the business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Renowned for its marks of excellence including the consumer recognized BSI Kitemark, BSI’s influence spans multiple sectors including Aerospace, Automotive, Built Environment, Food, Healthcare and ICT. With over 80,000 clients in 182 countries, BSI is an organization whose standards inspire excellence across the globe.

     

    What we offer:

     

    This position is located in our vibrant Herndon, Virginia office. We have about 125 employees on site with restaurants within walking distance, local gym discounts, free breakfast on Fridays, and fun company events. 

     

    BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.

     

    BSI is an Equal Opportunity Employer and we are committed to diversity.

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