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Job Title : Technical Specialist and Scheme Manager - In Vitro Diagnostic Devices, Medical Devices
Location : APAC-home based (local language required)
Purpose of the position
- Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise
- Deliver technical reviews, scheme management in support of the CE marking schemes
- Provide Medical Device OMS assessment and device expertise leadership and mentoring in areas of competence to Healthcare personnel
- Provide "Technical Sales / Networking" support to the commercial team
Key Responsibilities & Accountabilities
Deliver Medical Device CE Marking technical review, scheme management as a fully integrated member of the IVD TeamWork with IVD team and other team leaders as required to provide assessment within area of expertiseProvide advice and support to product specialists and scheme managers on certifications in area of expertise that may have a regulatory challengeKey Result Areas
Delivery of Medical Device CE Marking technical review, scheme management for the IVD TeamFully compliant Notified Body with no systematic non-conformities at auditDelivery of all services to time and quality, with positive feedback from clients and colleaguesThorough, prompt reporting back from meetings with third parties and effective handling of issues that ariseTimely handling of projects falling within area of specialism, whether performed personally or by other BSI staff under supervisionBSI becomes the Notified Body of first consultation by prospective clients and regulatory service providers through positive impact of BSI service levelPersonal growth in chosen area of expertise and business development supportKey Performance Indicators
Annual business financial KPlsOperational KPlsCompetent Authority Audit resultsMedical device external training business performanceInternal training programme successPerson Specification
Knowledgeand Experience (e.g.Type,level)
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 evaluationThorough knowledge of Medical Device regulations, ISO 13485 and have a broad technical understanding of the medical device industryA good understanding of product certification concepts and principlesA comprehensive understanding of quality systems, philosophies and principles and internal auditing principles and practicesAn understanding of BSI, its role and its approach to product certification policiesA good understanding of the application of accreditation / designation, notified body, product and quality systems standards and requirementsSkillsand Abilities(e.g.Teamwork, IT,Communication, Relationships)
Conceptualandanalyticalthinking, efficiency and results orientationAteamplayergoodatrelationship building internally and externallyBroadtechnicalunderstandingofclient industryproductsGeneral knowledge of business principlesandoperatingpractices (commercial awareness).Abilitytounderstandandinterpret legislationQualifications (e.g.Technical)
First or second degree in a discipline relevanttomedicaldevicemanufacture anduse, orequivalentqualificationLocal language required and local hire.PersonalQualities / Aptitudes e.g.Initiative,flexibility, commitment, reliability)
Goodinterpersonalskills,particularly communicationandinfluencingskillsCapable ofoperatingwithhorizontal and vertical reporting lines.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.
