R&D expert CE technical- Active Medical Device

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Job Title:     Technical and Scheme Manager – Active Devices

Reports to:  Technical Team Manager, Active Devices

Location:     Home Based – China /Japan  /Taiwan (home based)

The Scheme Manager will be a member of the Active Devices Team reporting to a Technical Team Manager, Active Devices and working as a colleague with other members of the Medical Devices Business Stream.

Purpose of the position:

• Manage a portfolio of Medical Device CE marking and ISO 13485 clients.
• Manage client projects, acting as their primary contact and make certification recommendations for CE and ISO certificates.
• 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 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 specialist support to the commercial team when required.
• Build strong relationships with clients and stakeholders to promote BSI.

Key Responsibilities & Accountabilities:

• Manage certification projects for a variety of medical device manufacturers.
• Deliver all services within required timescales and to a high quality.
• 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.
• Conduct quotation reviews, contract reviews, process applications, and compile certification decisions under the CE and ISO 13485 certification schemes.
• Provide advice and support to technical specialists and scheme managers on certifications in area of expertise that may have a regulatory challenge.
• Coordinate and run client project management meetings to facilitate CE marking processes.
• Oversee assessment work to ensure that BSI delivers its services to budget and on time.
• Plan and prioritise tasks logically according to regulatory priority, service level obligations and the needs of the business.
• Undertake all activities in accordance with BSI Policies, Procedures and Protocols.
• Maintain client satisfaction whilst continuing to meet BSI’s ethical expectations and all regulatory requirements.
• 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.
• Maintain and expand competence in areas of Medical Devices certification
• Support the Commercial Team as it grows the customer base worldwide.

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 Competent Authority audit non-conformances.
• Timely handling of projects falling within area of specialism, either directly or by supporting and coaching other BSI colleagues within remit.
• To achieve and maintain required competencies in order to fulfil the role.
• Successful completion of BSI Internal Training courses.

Desirable Criteria:

• Knowledge of Medical Devices Directive and Regulation.
• 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.
• Familiar with query resolution and complaints handling.

Qualifications:

• Above bachelor degree, relevant to active medical device design, development, manufacture and use i.e. electro-mechanical, electronic/electrical, biomedical engineering, medical physics or similar.
• 4 years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research or quality assurance or regulatory affairs of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
• Conceptual and analytical thinking, efficiency and results orientation.
• Ability to work independently with minimal supervision; self-motivated, proactive and results-orientated.
• Customer orientated with a focus on efficiency and delivery.

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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.