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Global Scientific Regulatory Lead, IVDR
- Permanent
- Project Manager
- Switzerland
This vacancy has now expired. Please see similar roles below...
Proclinical are recruiting a Global Scientific Regulatory Lead, IVDR for a medical technology and device organisation. This role is on a permanent basis and can be located in various parts of Europe such as Geneva, Barcelona, London or Paris. The client is focused on being one of the largest diagnostics suppliers.
Responsibilities:
- Supervise the execution of the program in all labs that own in-house tests and guarantee that all actions are conducted rendering to the needs and times.
- Enable the communication and sharing of best techniques and good examples.
- You will determine, adhere to and report sufficient KPIs to track progress.
- Conduct the IVDR readiness assessment of all commercial CE-IVD devices' group providers annually working alongside the group procurement team.
- Guarantee that all the information and data are shared and visible by all labs.
- The ideal candidate will follow up on queries and possible issues escalated by the labs, develop and execute mitigation and solution plans and actions.
- Assist in the delivery of training when required and suitable.
- Offer program updated to the senior management team as well as the steering committee.
- Other duties may be assigned to this role.
Skills & Requirements:
- Educated to an advanced degree level in a biology or pharmacy discipline.
- Familiarity with clinical labs.
- Know-how of ISO 15189.
- Acquaintance with project management and in quality.
- Fluency in the English language.
- Presentation and communication skills both verbally and in writing.
- Interpersonal abilities with the capacity to manage relations.
- Capable of influencing and directing others at all levels of management.
- An outgoing and energetic individual who is comfortable working within a flat non-hierarchical setting.
- An organised, thorough and independent individual.
- Willing to travel or business needs up to 25% of the time.
If you are having difficulty in applying or if you have any questions, please contact Josh Volpe at +44 203 800 1292.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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