|Job Title:||Standardization Manager | eHealth|
|Contact Name:||Jianghui Zhang|
|Job Published:||about 1 year ago|
Job title: Standardization Manager | eHealth
Location: Leuven, Belgium or Cambridge, UK
Our client is one of the fastest growing telecommunications and network solutions providers in the world.
This role requires familiarity with wearable devices and biomarkers, experience of European and international standardization and industry organizations in the medical device and digital health industries.
We are looking for a Standardization and Industry Development Manager, who will be responsible for guiding our client to prepare for existing and upcoming European regulations on medical devices and health data, participate in standardization work, and boost the health ecosystem in Europe via industry development activities.
The successful candidate will work alongside researchers, engineers and developers, who are involved in different aspects of the ecosystem. Therefore, commitment to collaborative problem-solving, deep insight of the health industry and sophisticated designs and the creation of health services are essential attributes.
Our client is putting together a new, dynamic and geographically-distributed team. The successful candidate will be given a choice of working either in Leuven (Belgium) or Cambridge (UK).
- Responsible for communicating with European medical device regulators (directly or via industry organizations) and help our client to design planning and roadmap for medical certification (e.g. CE marking).
- Participate in health industry organizations (e.g. COCIR) to drive the direction of the digital health industry, raise awareness and influence our client's devices, and build industry collaborations with partners.
- Have a broad, but specialist knowledge of design and development of biomarkers , eHealth devices and mobile applications.
- Knowledge of Health informatics, including point-of-care medical device communication, personal health device communication (e.g. wearables), service architecture, electronic health records (EHR), and interoperability of health information.
- Knowledge and experience of health/medical device standardization, e.g. Joint Initiative Council (JIC) for Global Health Informatics Standardization, CEN/TC 251, ISO/TC 215 and IEC TC 62.
- Understanding of the overall business picture in order to provide strategic advice to R&D and standardization teams.
Travelling: International travel, mostly within Europe (25% of the time post-pandemic).
Qualifications and Skills:
- Engineering or Computer Science degree or other related University degree.
- Familiarity with digital health applications, wearables and biomarkers.
- Have been involved in medical device regulatory activities and taken a leadership role, including but not limited to, working with regional regulators to define or implement medical device certification regulations or standards (e.g. MDD / MDR), working in health industry organizations to provide comments and feedback for regulation consultations, and working for medical company / clients to help them pursue medical certification (e.g. CE marking) or help define medical strategies.
- Have been involved in standardization organizations (e.g. CEN/TC 251, ISO/TC 215 and IEC TC 62), and actively contributed in the development of medical device and health informatics standards.
- Knowledge of the Open Source ecosystem and the libraries available for common tasks.
- Familiarity with cloud message APIs and push notifications.
- Ability to understand business requirements and translate these into technical requirements.
Languages: fluent English (spoken and written), French and/or Dutch considered as positive assets.
Desirable soft skills: Adaptability (including culture-sensitive outlook), written and verbal communication, time management and conflict management.
Others: Our client will offer a good competitive salary for the successful candidate.
How to apply: Please send your CV to Jianghui.email@example.com
Please note: The successful candidate must, by the start of the employment, have permission to work in the UK or in Europe.
Project People is acting as an Employment Business in relation to this vacancy.
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