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CE Marking Project Manager - General Medical Devices

at bsi.

Posted: 6/11/2019
Job Reference #: 10430

Job Description

  • Location(s)US-GA-Atlanta
    Contract Type
    Perm Full-Time
    Hiring Manager
    Kimberly Fitzwater
    Referral Bonus
    $3000 / £3000 / €3000 / 5% of Salary (AsiaPac)
  • The Opportunity

    Do you have experience within the medical field? Have you worked with Medical Devices previously? Would you like to work with cutting edge innovation and state of the art technologies?

    Due to continuing strategic growth within our Medical Devices business, we currently have vacancies for a Scheme Manager, also known as Project Manager. This is an excellent opportunity for a quality management professional to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients, and to be involved in the evaluation of cutting edge innovation and state of the art technologies.

    This is a home-based, full-time, salaried postion with up to 25% travel for trainings, team meetings, and client visits.

    Job Duties:

    • Deliver Medical Device CE Marking and ISO 13845 scheme (project) management
    • Provide advice and support to product specialists and scheme managers on certifications in area of expertise that may have a regulatory challenge
    • Participate in client meetings to facilitate CE marking processes
    • To conduct quotation reviews, contract reviews, process applications, and compile certification decisions under the CE and ISO 13485 certification schemes
    • Review assessment reports and other relevant documentation in order that sound judgements can be made for certification recommendation and be responsible for the integrity of the recommendation
    • Support the delivery of the surveillance audits and implement certificate changes, renewals
    • Ensuring appropriate qualification of external experts whose services may be required in the BSI CE certification process
    • Ensure certificates reflect the scheme and clients requirements, in order that the integrity of the scheme is consistently maintained
    • Maintain accurate records of activities, and competency records that meet regulatory and BSI procedural requirements
    • Keep up to date with regulatory requirements and maintain a high level of awareness of changes in standards relating to the voluntary and mandatory certification in Europe and internationally.
    • Manage the clients and their relationship with BSI in order to maintain and develop the value chain within targets
    • Undertake all activities in accordance with BSI Policies, Procedures and Protocols.

    About BSI

    Do you believe the world deserves excellence?

    BSI (British Standards Institution) has over 81,000 clients in 180 countries, and is an organization whose standards inspire excellence across the globe. BSI Medical Devices Notified Body provides rigorous CE and ISO 13485 certification to manufacturers globally. The team apply their knowledge to 3rd party conformity assessment of all types of medical devices; active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, wound care devices and many others. The team has doubled in size over the past eight years, demonstrating the company’s desire to succeed and deliver world beating results. There are exciting opportunities for further growth of the Medical Devices team.

    About You

    Job Requirements:

    • Experience with one or more of the following medical device specialties: soft tissue implants, wound care, ophthalmic devices, IVF, contraceptives, device/drug combination products
    • Thorough knowledge of the design and development of medical devices in area of experience, including the principles of design control, risk management and performance or clinical evaluation
    • Thorough knowledge of Medical Device regulations
    • Broad technical understanding of client industry products
    • Knowledge of business processes and the application of quality management standards
    • 4+ years in industry or relevant experience
    • Bachelor's degree in discipline relevant to medical devices

    Preferred Skills/Abilities:

    • Ability to communicate horizontally and vertically within the organisational structure, and externally with BSI clients
    • Ability to understand, interpret, and explain legislation
    • Ability to adapt in challenging situations whilst maintaining strict adherence to statutory requirements
    • Sound administration, organisation and project management skills, with attention to detail
    • Computer literate and familiar with commonly used software tools (e.g. Windows, Excel, Word) and ability to learn BSI systems e.g. Darwin
    • Ability to plan and prioritise tasks according to importance to the customer and business needs
    • Ability to judge significance and clearance of non-conformities