Overview
As Technical Specialist & Scheme Manager, you will support the certification of active medical devices for the European market. You will review technical and clinical documentation, manage certification activities, and provide regulatory guidance across CE marking schemes. The role blends engineering judgment with regulatory expertise to ensure patient safety and compliance. You will work with manufacturers and cross-functional teams, shaping how devices reach the market. This is a home-based position with global reach and growth through ongoing training.
Leistungen / Benefits
- competitive total reward package
- flexible working hours
- ongoing training and development
- flexible benefits
Verantwortungsbereiche
- Review medical device documentation for compliance with MDD 93/42/EEC, MDR 2017/745 and UK MDR 2012
- Manage certification activities for a portfolio of manufacturers, including auditing requirements and CE certification decisions
- Provide regulatory, operational, and strategic support to scheme managers and product specialists
- Provide leadership and mentoring in medical device expertise to personnel
Zentrale Anforderungen
- Minimum 5 years of design and development, R&D, or testing experience with active medical devices
- Thorough knowledge of Medical Device regulation, including IEC 60601 Third Edition and ISO 14971 awareness
- Understanding of design control and risk management principles
- Strong interpersonal communication and workload prioritization
- strong communication
- team collaboration
- prioritization
- MDD 93/42/EEC
- MDR 2017/745
- UK MDR 2012
Technical Specialist - Active Medical Devices in Dresden Arbeitgeber: BSI Group
BSI ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern die Möglichkeit bietet, in einem dynamischen und internationalen Umfeld zu arbeiten, während sie einen positiven Einfluss auf die Gesellschaft ausüben. Mit flexiblen Arbeitszeiten, kontinuierlicher Weiterbildung und einem starken Fokus auf Teamarbeit und persönliche Entwicklung fördert BSI eine inklusive Unternehmenskultur, die Innovation und Zusammenarbeit schätzt. Die Position des Head of AI Global Quality & Accreditation ermöglicht es Ihnen, als Branchenexperte zu agieren und aktiv zur Gestaltung von Richtlinien und Standards im Bereich Künstliche Intelligenz beizutragen.
