Other
Salary: Competitive Salary
Job Type: Full time
Experience: Senior Level
BSI
Scheme Manager Samd (Remote)
Scheme Manager Samd | BSI | Worldwide
Great that you’re thinking about a career with BSI!
Job Title: Scheme Manager – SaMD
Reports to: Global Head of SaMD
...Scheme Manager Samd | BSI | Worldwide
Great that you’re thinking about a career with BSI!
Job Title: Scheme Manager – SaMD
Reports to: Global Head of SaMD
Location: UK/EU – Homebased
Purpose of the position
- Build, control and project manage a portfolio of Medical Device CE marking and ISO 13485 clients
- Ensure timely delivery of scheme management and assessment services
- Ensure the integrity of the certification schemes and services provided
- Provide specialist regulatory, operational and strategic support to medical device Technical Specialists, Certification Specialists, Clinical Evaluation Specialists and the business in the delivery of CE medical device marking schemes
- Provide Medical Device expertise, leadership and mentoring in areas of competence to medical devices personnel
- Provide “Technical Sales/Networking” support to the commercial team and promote BSI
- Provide in-house and external training in the field of medical device regulation
- Build strong relationships with clients and stakeholders to promote BSI
Key Responsibilities & Accountabilities
- Deliver Medical Device CE Marking and ISO 13845 scheme management
- Oversee assessment work to ensure that BSI delivers its services to budget and on time
- 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 and 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.
- Plan and prioritise tasks logically according to regulatory priority, service level obligations and the needs of the business
Key Performance Indicators
- Annual business financial KPIs
- Meet operational and regulatory KPIs – as defined in the PDR/annual objectives
- Delivery of all services to time and quality, with positive feedback from customers (internal and external)
- Delivery of all services to a high standard in accordance with Regulatory requirements and BSI procedures, with a focus on eliminating Regulatory Authority audit non-conformances
- Timely handling of projects falling within the area of specialism, either directly or by supporting and coaching other BSI colleagues within the remit
- To achieve and maintain the required competencies in order to fulfil the role
Knowledge and Experience
- 5+ years working on the design and development of SaMD products
- Proven track record of managing and delivering medical device design or manufacturing projects
- Thorough knowledge of the development of SaMDs
- Working knowledge of the Medical Device regulation
- Knowledge of business processes and the application of ISO 13485 quality management standards or similar regulated industry quality systems
- 5+ years in industry or relevant experience
- Experience in the compilation and maintenance of technical files or design dossiers used to support CE certificate applications
- Experience in product verification and validation and risk management
Qualifications
- BSc, MSC or PhD degree in a discipline relevant to Software, Medical device manufacture and use, or equivalent qualification
- Ability to travel approximately 10-15%, including internationally
- First or second degree in discipline relevant to, and applicable to medical devices regulation
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.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
