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Abbott is recruiting a Regulatory Affairs Manager to be based in Paris, France.

Your responsibilities include:

• 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.

Your Profile:

• 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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com