- Review and approval of advertising and promotional materials in France.
- Preparation and submission to the French Competent Authorities all advertising and promotional materials requiring a prior approval from ANSM per the local regulatory requirements.
- Notification of placing on the market of new products in France to ANSM.
- Maintenance of existing notifications, and management of changes to existing notifications, in relation to the new European Medical Device Regulation.
- Notification to the French competent authorities of new reimbursed products (LPPR declaration)
- Declaration to the French competent authority of the Economic Operator activity (Affiliate as Distributor)
- Provide regulatory support to the French Commercial team on tenders and field requests (from sales team, marketing team and reimbursement team): CE certificates, IFU, labels, ISO and EU MDR questions
- Provide local support and responses to technical queries, e.g. MRI compatibility, latex/PVC content.
- Support and respond to GDPR questions as appropriate.
- Support and respond to Privacy Shield questions as appropriate.
- Provide regulatory affairs support and input to internal and external audits.
- Provide regulatory training to employees.
- Minimum Bachelor degree (degree in a technical or science discipline highly preferred).
- Knowledge of EU medical device regulations and Quality Management Systems for medical devices.
- 3-5 years relevant experience within regulatory function in medical devices industry and knowledge of regulatory requirements in France (CE marking)
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Fluency in French and English
- Strong analytical skills
- Customer oriented attitude with strong communication skills
- Attention to detail and accuracy is required.
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Regulatory Affairs Associate Manager
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il y a 1 semaine
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il y a 3 jours
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Jobs for Humanity Paris, FranceCompany Description · Jobs for Humanity is dedicated to building an inclusive and just employment ecosystem. Therefore, we have dedicated this job posting to individuals coming from the following communities: Refugee, Neurodivergent, Single Parent, Blind or Low Vision, Deaf of Ha ...
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Regulatory Affairs Manager - Issy-les-Moulineaux, France - Abbott
Description
Abbott is recruiting a Regulatory Affairs Manager to be based in Paris, France.
Your responsibilities include:
Your Profile: