Great that you're thinking about a career with BSI!
Job title: Scheme Manager
Location: Home based
Salary: Competitive and negotiable
Due to continuing strategic growth within our Medical Devices business, we currently have vacancies for Regulatory Project Managers (known internally as Scheme Managers) within the Orthopaedic and Dental team. This is an excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients globally, 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 position with up to 25% travel for training, team meetings, and client visits.
Scheme Manager- O&D; Responsibilities:
- 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
- Experience with one or more of the following medical device specialties: orthopaedic implants, dental implants, dental materials.
- 4+ years in industry or relevant experience including experience with project/program management
- 2 years direct or indirect work within an R&D; setting
- Bachelor's or Master’s degree in discipline relevant to medical devices
- Ability to adapt in challenging situations whilst maintaining strict adherence to statutory requirements
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
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